Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C67497 CDISC Glossary CDISC Glossary CDISC Glossary The terminology of the Clinical Data Interchange Standards Consortium (CDISC) glossary. CDISC Glossary Terminology C80442 C67497 CDISC Glossary 510(k) 510(k). Premarket Notification (PMN) required for certain medical devices. See http://www.fda.gov/cdrh/510khome.html. Premarket Device Notification C42610 C67497 CDISC Glossary abbreviation A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. NOTE: An abbreviation is NOT pronounced as a word, but each letter is read in sequence (e.g., NIH). Compare to acronym. Abbreviation C71733 C67497 CDISC Glossary absorption The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes. See also ADME (pharmacokinetics). Biological Absorption C156638 C67497 CDISC Glossary accelerated approval fast track designation Regulatory mechanism by which new drugs meant to treat serious life-threatening diseases and that provide meaningful therapeutic benefit to patients over existing treatments can be approved rapidly. [after FDA, Guidance for Industry Expedited Programs for Serious Conditions - Drugs and Biologics; after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource https://www.ncbi.nlm.nih.gov/books/NBK338448/] Accelerated Approval C93495 C67497 CDISC Glossary acronym A word formed from the beginning letters (e.g., ANSI) or a combination of syllables and letters (e.g., MedDRA) of a name or phrase. NOTE: An acronym is usually pronounced as a word, not by speaking each letter individually. Compare to abbreviation Acronym C142550 C67497 CDISC Glossary action letter An official communication from FDA to an NDA sponsor announcing an agency decision. See also approval letter, approvable letter, not-approvable letter. FDA Action Letter C142528 C67497 CDISC Glossary activation (EDC) Enabling an eClinical trial system to capture data; usually used for EDC systems. Electronic Data Capture Activation C95337 C67497 CDISC Glossary active ingredient dose active substance dose The amount of a single active substance administered in a single dose. Active Ingredient Dose C82533 C67497 CDISC Glossary active ingredient Any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [After 21 CFR 210.3(b)(7)] Active Ingredient C202486 C67497 CDISC Glossary active substance Substance responsible for the activity of the medicine. NOTE: The protocol may define the active substance in terms of the Anatomical Therapeutic Chemical (ATC) code (level 3-5). [EMA Glossary of regulatory terms; EU Reg 536/2014] See also international nonproprietary name (INN), generic name. Active Substance C98704 C67497 CDISC Glossary adaptive design A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. [Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry, FDA] See also master protocol. Adaptive Design C142382 C67497 CDISC Glossary adequate and well-controlled studies Studies used to support drug marketing authorization and intended to provide substantial evidence of effectiveness required by law to support a conclusion that a drug is effective. NOTE: For additional information see COA glossary of terms. [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. 21 CFR 314.126] Adequate and Well-controlled Study C142383 C67497 CDISC Glossary administrable dosage form Pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out. [After ISO 11615 Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information, Second edition 2017-10] See also route of administration, administration (substance). Administrable Dosage Form C25409 C67497 CDISC Glossary administration (substance) The act of introducing a substance into or onto the body. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also route of administration, administrable dosage form. Administration C142384 C67497 CDISC Glossary admission criteria Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study. See also inclusion criteria, exclusion criteria. Admission Criteria C142385 C67497 CDISC Glossary adverse drug reaction (ADR) adverse drug experience Any noxious and unintended response associated with the use of a drug in humans. NOTE: 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. 3. FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [WHO Technical Report 498(1972); ICH E2A] Adverse Drug Reaction C41331 C67497 CDISC Glossary adverse event (AE) adverse experience; side effects Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. an adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A] See also serious adverse event, serious adverse experience. Adverse Event C41332 C67497 CDISC Glossary adverse reaction A response to a medicinal product, devices, or procedures, which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. In the context of drug development, the term is used as a synonym of adverse drug reaction. (After ICH E2A) Adverse Reaction C156645 C67497 CDISC Glossary AEGIS (ADROIT Electronically Generated Information Service) A subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency ADROIT (Adverse Drug Reaction On-line Information Tracking) database. ADROIT Electronically Generated Information Service C156646 C67497 CDISC Glossary AHIC (American Health Information Community) A US government-charted commission providing input and recommendations to HHS on how to make health records digital and interoperable, and assure the privacy and security of those records (HITSP). American Health Information Community C156622 C67497 CDISC Glossary ALCOA + ALCOA Plus Acronym for a number of attributes or dimensions included in ALCOA, plus the following: Complete, Consistent, Enduring, and Available when needed. NOTE: ALCOA + is a recent way to summarily refer to the attributes or dimensions of data integrity.) After EMA Reflection Paper on eSOURCE in effect since 2010. See also WHO Annex V, Guidance on Good Data and Record Management Practices. See also ALCOA, data integrity. Attributable, Legible, Contemporaneous, Original, Accurate Plus C156621 C67497 CDISC Glossary ALCOA Acronym for a number of attributes or dimensions that are considered of universal importance for data integrity of source data and the records that hold those data. These include that the data and records be: A-Attributable (to both subject and to any actor on a record); L-Legible (available for human review, possible to read electronically if an encoded eRecord); C-Contemporaneous (timing of data collection with respect to the time the observation is made: the more promptly an observation is recorded, the better the quality.); O-Original (the first suitably accurate and reliable recording of data for the intended purpose); A-Accurate (free from error especially as the result of care; an accurate diagnosis conforming exactly to truth or to a standard). NOTE: ALCOA stemmed from FDA's Dr. Stan Woollen's talks in the early 90's on earmarks for the quality of records and has become a widespread acronym reflecting best practices for clarity and usability of data. [From EMA Reflection Paper on eSOURCE in effect since 2010] See also: Data Quality and the Origin of ALCOA. See also: Six Primary Dimensions for Data Quality Assessment. See also ALCOA+, data integrity. Attributable, Legible, Contemporaneous, Original, Accurate C142753 C67497 CDISC Glossary alert To cause a high-priority signal (or warning) to be transmitted to the relevant stakeholder by way of the local system or another system (usually according to an established set of rules). For example, the system may transmit an alert to a patient's cardiologist that the patient has experienced another heart attack. another example is that the pharmacy system may transmit an alert to the prescribing physician that a potentially dangerous drug-drug interaction may occur based on the current list of medications. another example is that the system may notify a patient's physician that laboratory results (that are not within normal limits) are available. [HL7 EHR-SFM Glossary of Terms, 2010] System Alert C16275 C67497 CDISC Glossary algorithm Step-by-step procedures for making a series of choices among alternative decisions to reach a calculated result or decision. NOTE: An algorithm may be used clinically to guide treatment decisions for an individual patient on the basis of the patient's clinical outcome or result. [after AMA Style Guide, 9th Edition] Algorithm C142387 C67497 CDISC Glossary alpha error The likelihood that a relationship observed between two variables is due to chance. The probability of a Type 1 error. [Modified from AMA Manual of Style] Alpha Error C41200 C67497 CDISC Glossary amendment A written description of a change(s) to, or formal clarification of, a document. Amendment C142388 C67497 CDISC Glossary American National Standards Institute (ANSI) Founded in 1918, ANSI itself does not develop standards. ANSI's roles include serving as the coordinator for US voluntary standards efforts, acting as the approval body to recognize documents developed by other national organizations as American National Standards, acting as the US representative in international and regional standards efforts, and serving as a clearinghouse for national and international standards development information. [HL7] American National Standards Institute C142389 C67497 CDISC Glossary analysis dataset An organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to a database table. NOTE: standardizing analysis datasets is intended to make review and assessment of analysis more consistent [ADaM]. Analysis Dataset C142390 C67497 CDISC Glossary analysis set A set of subjects whose data are to be included in the main analyses. This should be defined in the statistical section of the protocol. NOTE: There are a number of potential analysis sets, including, for example, the set based upon the intent-to-treat principle. [ICH E9] Analysis Set of Subjects C142391 C67497 CDISC Glossary analysis variables Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. See also variable. Analysis Variable C142436 C67497 CDISC Glossary anchor Designation for a planned activity, often marking the transition between epochs or elements of a clinical study plan (e.g., "FPFV-first patient first visit"). Clinical Study Anchor C142392 C67497 CDISC Glossary anonymization The process of protecting privacy that removes the association between the identifying data and the data subject. In anonymized data, the patient cannot be identified by the recipient of the information. [ISO TS 25237:2008; TransCelerate Protection of Personal Data in Clinical Documents - A Model Approach] Anonymization C156629 C67497 CDISC Glossary anticipated adverse event Other adverse events that are not study endpoints and are not "expected" (i.e., because they are not in the investigator's brochure) that can be anticipated to occur with some frequency during the course of the trial, regardless of drug exposure, depending on the patient population and disease under study. NOTE: Examples of such "anticipated" events include known consequences of the underlying disease or condition under investigation, events anticipated from any background regimen, or re-emergence or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies] Anticipated Adverse Event C142393 C67497 CDISC Glossary applet A small application, typically downloaded from a server. Applet C142394 C67497 CDISC Glossary applicable regulatory requirement(s) Any law(s) or regulation(s) addressing the conduct of clinical trials of investigational products. [ICH E6(R2) Glossary, 1.4] Applicable Regulatory Requirement C142551 C67497 CDISC Glossary approvable letter An official communication from FDA to an NDA/ BLA sponsor that lists issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)] FDA Approvable Letter C70800 C67497 CDISC Glossary approval (in relation to Institutional Review Boards) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. [ICH E6] Institutional Review Board Approval C70799 C67497 CDISC Glossary approval letter An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)] Approval Document C15538 C67497 CDISC Glossary arm (protocol) A planned path through the study that describes which treatments and/or controls apply to the subjects as they progress through the study. [After BRIDG] See also control, control group. Protocol Treatment Arm C16309 C67497 CDISC Glossary artificial intelligence (AI) A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017)] See also machine learning, deep learning, natural language processing, synthetic data. Artificial Intelligence C25217 C67497 CDISC Glossary assessment The interpretation or evaluation of an obtained value by using a test, tool, instrument, or expert judgement of the status of a study subject. [After BEST Resource] See also variable, outcome, endpoint. Assessment C25358 C67497 CDISC Glossary attributable A quality by which records and data can be traced back to the subject to whom they pertain, as well as to those persons who have acted on the records. Attribution C62618 C67497 CDISC Glossary attribute (n) In data modeling, refers to specific items of data that can be collected for a class. Computer Programming Object Attribute C115469 C67497 CDISC Glossary audit certificate Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company). [ICH E6 Glossary] Audit Certificate C142395 C67497 CDISC Glossary audit report A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary] Audit Report C142396 C67497 CDISC Glossary audit trail A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. [after ICH E6, CSUICI] Audit Trail C45269 C67497 CDISC Glossary audit A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary] Audit C156618 C67497 CDISC Glossary authorised auxiliary medicinal product A medicinal product that is currently authorised for marketing in a country or region, that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product, regardless of labelling of the auxiliary medicinal product. [after EU CTR] Authorized Auxiliary Medicinal Product C156617 C67497 CDISC Glossary authorised investigational medicinal product A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [After EU CTR (EU) No 536/2014] See also investigational medicinal product. Authorized Investigational Medicinal Product C41192 C67497 CDISC Glossary authorization The process of giving someone permission to do or have something. In multi-user computer systems, a system administrator defines for the system which users are allowed access to the system and what privileges of use are permitted. [HL7 EHR-S FM Glossary of Terms, 2010]. Authorization C156473 C67497 CDISC Glossary auxiliary medicinal product A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. NOTE: Auxiliary medicinal products may be authorised for marketing in a country or region or non-authorised. [after EU-CTR] Auxiliary Medicinal Product C142397 C67497 CDISC Glossary back translation (natural language) The process of translating a document that was translated from one language to another back to the original language. Used to ensure that consent forms, surveys, and other clinical trial documents will be clear and accurate in the translated form. Back Translation C142649 C67497 CDISC Glossary background material Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features. Protocol Background Material C165822 C67497 CDISC Glossary background treatment Medicinal products that are administered to each clinical trial subject, regardless of randomization group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017] Background Treatment C142398 C67497 CDISC Glossary balanced study Trial in which a particular type of subject is equally represented in each study group. Balanced Study C142399 C67497 CDISC Glossary bandwidth An indicator of the throughput (speed) of data flow on a transmission path; the width of the range of frequencies on which a transmission medium carries electronic signals. All digital and analog signal channels have a bandwidth. Bandwidth C142400 C67497 CDISC Glossary baseline assessment Assessment of subjects as they enter a trial and before they receive any treatment. Baseline Assessment C142401 C67497 CDISC Glossary baseline characteristics Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered. NOTE: Randomized, controlled trials aim to compare groups of participants that differ only with respect to the intervention (treatment). although proper random assignment prevents selection bias, it does not guarantee that the groups are equivalent at baseline. any differences in baseline characteristics are, however, the result of chance rather than bias. The study groups should be compared at baseline for important demographic and clinical characteristics. Baseline data may be especially valuable when the outcome measure can also be measured at the start of the trial. [CONSORT statement] Baseline Characteristics C142402 C67497 CDISC Glossary baseline imbalance A systematic error in creating intervention groups, such that they differ with respect to prognosis. That is, the groups differ in measured or unmeasured baseline characteristics because of the way participants were selected or assigned. NOTE: also used to mean that the participants are not representative of the population of all possible participants. [ICH E9] Baseline Imbalance C202580 C67497 CDISC Glossary basket trial design A type of trial design under a master protocol designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol. Basket Trial Design C142403 C67497 CDISC Glossary Bayesian approaches Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g., treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the basis for statistical inference. [ICH E9 Glossary] Bayesian Approach C142404 C67497 CDISC Glossary Bayesian statistics Statistical approach named for Thomas Bayes (1701-1761) that has among its features giving a subjective interpretation to probability, accepting the idea that it is possible to talk about the probability of hypotheses being true and of parameters having particular values. Bayesian Statistics C142405 C67497 CDISC Glossary beta error Probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis. See also Type 2 error. [AMA Manual of style] Beta Error C28232 C67497 CDISC Glossary bias Bias refers to defects in study design, measurement, analysis or interpretation such that they cause a result to depart from the true value in a consistent direction. [after AMA Manual of style, ICH E9, CONSORT Statement] Bias C16341 C67497 CDISC Glossary bioanalytical assays Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids. Bioassay C70913 C67497 CDISC Glossary bioavailability Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body. Bioavailability C71763 C67497 CDISC Glossary bioequivalence Scientific basis on which drugs with the same active ingredient(s) are compared. NOTE: To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions. Bioequivalence C307 C67497 CDISC Glossary biological product A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition. Such products may include virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product. NOTE: Biological products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Biological products are generally large, complex molecules and are often more difficult to characterize than small molecule drugs. [After 21 CFR 600.3; After FDA Biological Product Definitions] See also vaccine, cell therapy, gene therapy, pharmaceutical product, drug product, medicinal product. Biological Agent C71778 C67497 CDISC Glossary Biologics licensing application (BLA) Biologics licensing application (BLA). an application to FDA for a license to market a new biologic product in the United states. Biologics License Application C16342 C67497 CDISC Glossary biomarker biological marker A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives. Categories of biomarkers include: susceptibility/risk biomarker; diagnostic biomarker; monitoring biomarker; prognostic biomarker; predictive biomarker; safety biomarker; pharmacodynamic/response biomarker. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] Biomarker C142406 C67497 CDISC Glossary biometric signature A signature based on the verification of an individual's identity, based on measurement of the individual's physical feature(s) or repeatable action(s), where those features and/or actions are both unique to that individual, and measureable [21 CFR 11] Biometric Signature C156644 C67497 CDISC Glossary biosimilar A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components. This requires that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (see section 351(i)(2) of the PHS Act). [after FDA, Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product] Biosimilar C16347 C67497 CDISC Glossary biostatistics Branch of statistics applied to the analysis of biological phenomena. Biostatistics C142407 C67497 CDISC Glossary blind review Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis. [Modified ICH E9] Blind Review C142408 C67497 CDISC Glossary blinded (masked) medications Products that appear identical in size, shape, color, flavor, and other attributes to make it very difficult for subjects and investigators (or anyone assessing the outcome) to determine which medication is being administered. Blinded Medication C70840 C67497 CDISC Glossary blinded study A study in which the subject, the investigator, or anyone assessing the outcome is unaware of the treatment assignment(s). NOTE: Blinding is used to reduce the potential for bias. [Modified ICH E6 Glossary] See also blinding/masking, double-blind study, single-blind study, triple-blind study; contrast with open-label or unblinded study. Blinded Clinical Study C49068 C67497 CDISC Glossary blinding A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. [After Abhaya Indrayan, Martin P. Holt. Concise Encyclopedia of Biostatistics for Medical Professionals. Chapman & Hall; November 17, 2016] See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study, masking. Blinded C28221 C67497 CDISC Glossary blood draw The collection of blood from a vein, most commonly via needle venipuncture. (NCI) Phlebotomy C142701 C67497 CDISC Glossary branch Point within a study design where there is an allocation of subject subsets to particular procedures or treatment groups. Study Branch C80012 C67497 CDISC Glossary browser Computer program that runs on the user's desktop computer and is used to navigate the World Wide Web. See also web browser. HTML Browser C63626 C67497 CDISC Glossary cache Storage area on a computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements. Memory Cache C142409 C67497 CDISC Glossary carry-over effect Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity. Carry-Over Effect C142588 C67497 CDISC Glossary case history An adequate and accurate record prepared and maintained by an investigator that records all observations and other data pertinent to the investigation of each individual administered the investigational drug (device or other therapy) or employed as a control in the investigation. NOTE: Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study. [21 CFR 312.62(b)] Investigational Subject Case History C40988 C67497 CDISC Glossary case report form (CRF) case record form A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject. NOTE: In common usage, CRF can refer to either a CRF page, which denotes a group of one or more data items, linked together for collection and display, or a casebook, which includes the entire group of CRF pages on which a set of clinical study observations can be or have been collected by completion of such CRF pages for a subject in a clinical study. See also CRF (paper), eCRF. [ICH E6 Glossary, FDA Final Guidance on eSource]. Case Report Form C142411 C67497 CDISC Glossary case report tabulations (CRT) In a paper submission, listings of data that may be organized by domain (type of data) or by subject. See also eCRT. Case Report Tabulation C15197 C67497 CDISC Glossary case-control study Retrospective study in which individuals with an outcome (cases) are compared with those who do not have the outcome (controls). The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure (e.g., treatment) is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study, exposure. Case-Control Study C142412 C67497 CDISC Glossary categorical data Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories. Categorical Data C142413 C67497 CDISC Glossary causality assessment An evaluation performed by a medical professional concerning the likelihood that a therapy or product under study caused or contributed to an adverse event. Causality Assessment C142415 C67497 CDISC Glossary CDISC Library A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. NOTE: Formerly known as CDISC SHARE. [CDISC] CDISC Library C142416 C67497 CDISC Glossary CDISC standards A set of models, implementation guides, controlled vocabularies, and exchange formats developed by the Clinical Data Interchange Standards Consortium (CDISC), which are intended to provide for consistent use of common representations of data, terms and specifications. NOTE: These standards apply to translational research, electronic submission of clinical data, and the life-cycle of clinical product development, which includes protocol representation, data collection, aggregation, tabulation, and analysis and unambiguous information exchange across disparate systems. [After https://www.ncbi.nlm.nih.gov]. See also standard, data standards, Study Data Standardization Plan, and Standards Development Organization. CDISC Standard C70601 C67497 CDISC Glossary cell therapy The prevention or treatment of human disease by the administration of cells that have been selected, multiplied, and pharmacologically treated or altered outside the body (ex vivo), or methods (pharmacological as well as nonpharmacological) to modify the function of intrinsic cells of the body for therapeutic purposes (in vivo). NOTE: Cell therapies can be classified based on therapeutic indication, cell type, source of cells, and underlying technology, among others, in medical and regulatory contexts. [After https://www.sciencedirect.com/topics/neuroscience/cell-therapy; After Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007.] See also regenerative medicine therapy, regenerative medicine advanced therapy, gene therapy, biological product. Cellular Therapy C142417 C67497 CDISC Glossary certified copy A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. [ICH E6 (R2)] Certified Copy C142418 C67497 CDISC Glossary certified IRB professional (CIP) Persons certified to participate on an institutional review board, who satisfy the educational and employment requirements and pass an examination conducted by the applied Research ethics national association (aRena), the membership division of Public Responsibility in Medicine and Research (PRiM&R). Certified IRB Professional C158128 C67497 CDISC Glossary challenge agent A non-investigational medicinal product (NIMP) given to trial subjects to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017] Challenge Agent C156647 C67497 CDISC Glossary CHI (consolidated health informatics) CHI began as an eGov initiative to establish a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to "speak the same language" based on common enterprise-wide business and information technology architectures. CHI is currently managed under the Office of the National Coordinator for Health Informational Technology's (ONC) Federal Health Architecture (FHA) Program Management Office. Ref: The United States Health Information Knowledgebase [USHIK]. [HITSP] Consolidated Health Informatics C41106 C67497 CDISC Glossary class A definition of objects with properties (attributes, methods, relationships) that all objects in the class have in common. [HL7, 2001] in data modeling, a class defines a set of objects that share the same attributes, relationships, and semantics. A class is usually an entity that represents a person, place, or thing. Object Class C142419 C67497 CDISC Glossary clean database A set of reviewed data in which errors have been resolved to meet QA requirements for error rate and in which measurements and other values are provided in acceptable units; database that is ready to be locked. See also database lock, clean file. Clean Database C142420 C67497 CDISC Glossary clean file When all data cleaning is completed and database is ready for quality review and unblinding. Clean File C142421 C67497 CDISC Glossary client A program that makes a service request of another program, usually running on a server, that fulfills the request. Web browsers (such as Firefox and Microsoft explorer) are clients that request HTML files from web servers. Client Computer C142422 C67497 CDISC Glossary clinical benefit A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels. Clinical Benefit C142423 C67497 CDISC Glossary clinical clarification A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.). See also self-evident change. Clinical Clarification C15783 C67497 CDISC Glossary clinical data Data pertaining to the medical well-being or status of a patient. Category also includes clinical reports and individual patient data (IPD) as defined in the EMA Policy 0070 Implementation Guide. [http://www.ema.eoropa.eu/docs/en_GB/document_library/REPORT/2014/10/WC500174378.PDF] Clinical Data C142424 C67497 CDISC Glossary clinical development plan A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. NOTE: The plan should have appropriate decision points and allow modification as knowledge accumulates. [from ICH E9] See also development plan. Clinical Development Plan C142426 C67497 CDISC Glossary clinical document architecture Specification for the structure and semantics of "clinical documents" for the purpose of exchange. [HL7; SPL] Clinical Document Architecture C142425 C67497 CDISC Glossary clinical document A documentation of clinical observations and services. NOTE: an electronic document should incorporate the following characteristics: persistence, stewardship, potential for authentication, wholeness, and human readability. [SPL] Clinical Document C39547 C67497 CDISC Glossary clinical efficacy Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans. [SQA] Treatment Efficacy C142427 C67497 CDISC Glossary clinical encounter Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual. [CDISC] Clinical Encounter C70755 C67497 CDISC Glossary clinical hold (of a clinical trial) An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial). Study on Hold C142430 C67497 CDISC Glossary clinical investigation Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Considered synonymous with clinical research by FDA. See clinical study, clinical trial. [FDA Science & Research] Clinical Investigation C142552 C67497 CDISC Glossary clinical outcome assessment (COA) qualification A formal conclusion by FDA that, within the stated context of use, the results of the COA measurement can be relied upon to have a specific interpretation and application. NOTE: For qualified COAs, FDA permits drug developers to use the COA in the qualified context in IND and NDA/BLA submissions without requesting that the relevant CDER review group reconsider and reconfirm the suitability of the COA. [FDA Clinical Outcome Assessment (COA) Glossary] FDA Clinical Outcome Assessment Qualification C142378 C67497 CDISC Glossary clinical outcome assessment (COA) Any assessment that may be influenced by human choices, judgment, or motivation and may support or refute treatment benefit. NOTE: Unlike biomarkers that rely completely on an automated process or algorithm, COAs reflect interpretation of reporting from a patient, a clinician, or an observer. There are four types of COAs. See also patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO). [FDA Clinical Outcome Assessment (COA) Glossary] Clinical Outcome Assessment C16975 C67497 CDISC Glossary clinical pharmacology Science that deals with the characteristics, effects, properties, reactions, and uses of drugs, particularly their therapeutic value in humans, including their toxicology, safety, pharmacodynamics, and pharmacokinetics (ADME). Clinical Pharmacology C142435 C67497 CDISC Glossary clinical research and development The testing of a drug compound in humans primarily done to determine its safety and pharmacological effectiveness. Clinical development is done in phases, which progress from very tightly controlled dosing of a small number of subjects to less tightly controlled studies involving large numbers of patients. [SQA] Clinical Research and Development C25465 C67497 CDISC Glossary clinical research associate (CRA) Person employed by a sponsor or by a contract research organization acting on a sponsor's behalf, who monitors the progress of investigator sites participating in a clinical study. At some sites (primarily in academic settings), clinical research coordinators are called CRAs. Clinical Research Associate C51811 C67497 CDISC Glossary clinical research coordinator (CRC) clinical coordinator; research coordinator; study coordinator; trial coordinator Study site staff member who executes, manages, and coordinates research protocols in the clinic setting including screening, enrollment, monitoring of patient candidates/participants, and administration of informed consent. Other duties may be included depending on the study site. Clinical Coordinator C70668 C67497 CDISC Glossary clinical research subject A person who is enrolled into a clinical study or trial. See also study, trial, and study population. Clinical Study Subject C82562 C67497 CDISC Glossary clinical significance Change in a subject's clinical condition regarded as important whether or not due to the test intervention. NOTE: some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol. The term "clinical significance" is not advisable unless operationally defined. Clinical Significance C142437 C67497 CDISC Glossary clinical study data element A single observation associated with a subject in a clinical study. A data element in an eCRF represents the smallest unit of observation captured for a subject in a clinical investigation. NOTE: Examples include birth date, white blood cell count, pain severity measure, and other clinical observations made and documented during a study. Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. See also eCRF, data element identifier, data originator, item. [After FDA Guidance for Industry Electronic Source Data in Clinical Investigations , Body text and Glossary] Clinical Study Data Element C142439 C67497 CDISC Glossary clinical study report A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. NOTE: For further information, see the ICH Guideline for Structure and Content of Clinical Study Reports. [ICH E6 Glossary] Clinical Study Report C15206 C67497 CDISC Glossary clinical study A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. Clinical Study C142440 C67497 CDISC Glossary clinical trial authorization Authorization granted by a Medicines Regulatory Agency to conduct a clinical trial in a jurisdiction. NOTE: If an ethical committee allows a trial to proceed it is called an approval to proceed. [After ISO 11615:2017, 3.1.12] Clinical Trial Authorization C142441 C67497 CDISC Glossary clinical trial data Data collected in the course of a clinical trial. See also clinical trial information. Clinical Trial Data C142446 C67497 CDISC Glossary clinical trial exemption (CTX) A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application (generally within 35 working days). NOTE: Approval means that the company is exempt from the requirement to hold a clinical trial certificate (CTC). [UK] Clinical Trial Exemption C142447 C67497 CDISC Glossary clinical trial information Data collected in the course of a clinical trial or documentation related to the integrity or administration of that data. A superset of clinical trial data. Clinical Trial Information C142449 C67497 CDISC Glossary clinical trial materials Complete set of supplies provided to an investigator by the trial sponsor. Clinical Trial Material C142452 C67497 CDISC Glossary clinical trial registry A web-based publicly accessible platform for providing structured information about clinical trials. NOTE: Such registries help patients, family members, health care professionals, researchers, and the public identify studies in which they might participate. Some registries include clinical trial results. Examples include: EU Clinical Trials Register (EU CTR), for studies in the EU or the EEA after 1 May 2001; ClinicalTrials.gov, a web-based resource from the National Library of Medicine (NLM) in the US. [After International Committee of Medical Journal Editors] Clinical Trial Registry C156620 C67497 CDISC Glossary clinical trial results registry A web-based publicly accessible platform for providing structured summary results information about clinical trials. See also clinical trial registry. Clinical Trial Results Registry C71104 C67497 CDISC Glossary clinical trial Interventional Clinical Trial; Interventional Study A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT). Clinical Trial C142453 C67497 CDISC Glossary clinician-reported outcome (ClinRO) A type of clinical outcome assessment. A measurement based on a report that comes from a trained health-care professional after observation of a patient's health condition. [After BEST Resource] Clinician-reported Outcome C165824 C67497 CDISC Glossary co-packaged product Two or more separate products packaged together in a single package or as a unit and composed of drug and device products, device and biological products, or biological and drug products. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, cross-labeled product. Co-packaged Product C142454 C67497 CDISC Glossary codelist Finite list of codes and their meanings that represent the only allowed values for a data item. A codelist is one type of controlled vocabulary. See also controlled vocabulary. Codelist C80216 C67497 CDISC Glossary coding In clinical trials, the process of assigning data to categories for analysis. NOTE: Adverse events, for example, may be coded using MedDRA. Encode C142455 C67497 CDISC Glossary cognitive debriefing A qualitative research tool used to determine whether concepts and items are understood by patients in the same way that PRO instrument developers intend. NOTE: Cognitive debriefing interviews involve incorporating follow-up questions in a field test interview to gain better understanding of how patients interpret questions asked of them and to collect and consider all concepts elicited by an item. [from PRO Draft Guidance Glossary] Cognitive Debriefing C15208 C67497 CDISC Glossary cohort study Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study, cohort. Cohort Study C61512 C67497 CDISC Glossary cohort A group of individuals who share a common exposure, experience or characteristic or a group of individuals followed-up or traced over time in a cohort study. [AMA Manual of Style] See also cohort study. Cohort C54696 C67497 CDISC Glossary combination product A product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another and are referred to as "constituent parts" of the combination product). NOTE: A combination product might be a single-entity product, a co-packaged product or a cross-labeled product. [After 21 CFR 3.2 (e)] See also single-entity product, co-packaged product, cross-labeled product. Combination Product C142456 C67497 CDISC Glossary commercially confidential information (CCI) Any information contained in clinical reports or other documents that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the company (the Marketing Application Holder) and cause harm (if disclosed). [After EMA Policy 0070 implementation Guide] Commercially Confidential Information C19984 C67497 CDISC Glossary common data element (CDE) A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH. NOTE: The mark up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [NCI, CaBIG]. See also item, item (PRO), stem, data element, data element identifier. Common Data Element C142575 C67497 CDISC Glossary Common Technical Document A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use. [ICH] See also eCTD. ICH Common Technical Document C142457 C67497 CDISC Glossary comparative study One in which the investigative drug is compared against another product, either active drug or placebo. Comparative Study C142458 C67497 CDISC Glossary comparator (product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. [ICH E6 Glossary] See also control. Comparator C202465 C67497 CDISC Glossary compendial name A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. NOTE: Used for all drugs within the US. [After USP Nomenclature Guidelines (last revision on March 30, 2020)] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name. Compendial Name C142544 C67497 CDISC Glossary Competent Authority (CA) The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States. European Union Competent Authority C142734 C67497 CDISC Glossary compliance (in relation to trials) Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. [Modified ICH E6 Glossary] Trial Compliance C42608 C67497 CDISC Glossary computer application application software Software designed to fill specific needs of a user; for example, software for navigation, project management, or process control. Computer Application C142433 C67497 CDISC Glossary concept of interest In the context of clinical outcomes, the thing measured by a COA assessment (e.g., pain intensity). [After Clinical Outcome Assessment (COA) Glossary of Terms FDA FDA eCOA Glossary] Clinical Outcomes Assessment Concept of Interest C45728 C67497 CDISC Glossary concept Discrete notion having a single meaning. In a controlled vocabulary a concept is mapped to one or more of the words that convey its meaning. Concept C156640 C67497 CDISC Glossary concerned member state (CMS) A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. In the Mutual Recognition Procedure, one or more Member States that is a CMS is asked to mutually recognize the Market Authorization of the Reference Member State (RMS). [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Mutual Recognition Procedure (MRP) and Reference Member State (RMS). Concerned Member State C53324 C67497 CDISC Glossary confidence interval (CI) A measure of the precision of an estimated value. The interval represents the range of values, consistent with the data, that is believed to encompass the "true" value with high probability (usually 95%). The confidence interval is expressed in the same units as the estimate. Wider intervals indicate lower precision; narrow intervals, greater precision. [CONSORT Statement] Confidence Interval C16466 C67497 CDISC Glossary confidentiality Prevention of disclosure to other than authorized individuals of a sponsor's proprietary information or of a subject's identity. [ICH E6 Glossary] Confidentiality C142460 C67497 CDISC Glossary confirmatory trial Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result, pragmatic trial. Compare to exploratory trial. Confirmatory Trial C142461 C67497 CDISC Glossary conformity assessment The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body (NB). Conformity Assessment C16468 C67497 CDISC Glossary consent form informed consent form Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. it is designed to begin the informed consent process, which consists of conversations between the subject and the research team. if the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. Informed consent is sometimes administered electronically, i.e., eICF. See also informed consent. Consent Form C156633 C67497 CDISC Glossary construct validation (COA) construct validation (re COA) Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment (COA) conform to a priori hypotheses concerning logical relationships that should exist with other measures or characteristics of patients and patient groups. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation. Clinical Outcome Assessment Construct Validation C142462 C67497 CDISC Glossary consumer safety officer (CSO) FDA official who coordinates the review process of various applications. Consumer Safety Officer C156632 C67497 CDISC Glossary content validation (COA) content validation (re COA) Establishing from qualitative research the extent to which the clinical outcome assessment (COA) instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation. Clinical Outcome Assessment Content Validation C78690 C67497 CDISC Glossary content validity The extent to which a variable (for example, a rating scale) measures what it is supposed to measure. [ICH E9 Glossary] evidence from qualitative research demonstrating that the instrument measures the concept of interest, including evidence that the items and domains of an instrument are appropriate and comprehensive, relative to its intended measurement concept, population, and use. NOTE: Testing other measurement properties will not replace or rectify problems with content validity. [FDA Final PRO Guidance] Content Validity C142434 C67497 CDISC Glossary context of use In the context of clinical outcomes, a comprehensive statement that fully and clearly describes and justifies the way a COA is to be used and the drug development-related purpose of the use. NOTE: The context of use defines the boundaries within which the available data adequately justify use of the COA and describes important criteria regarding the circumstances under which the COA is qualified. [FDA Clinical Outcome Assessment (COA) Glossary] Clinical Outcomes Assessment Context of Use C142463 C67497 CDISC Glossary contingent subject trial contact Planned response to an anticipated but conditional event in a clinical trial. [CDISC Trial Design Project] Contingent Subject Trial Contact C54148 C67497 CDISC Glossary contract research organization (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. [ICH E6 Glossary] Contract Research Organization C115464 C67497 CDISC Glossary contract A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. [ICH E6 Glossary] Contractual Agreement C28143 C67497 CDISC Glossary control group The group of subjects in a controlled study that receives, for example, no treatment, a standard treatment, or a placebo. [21 CFR 314.126] See also control, controlled study, arm (protocol). Control Group C142464 C67497 CDISC Glossary control of electronic records To prepare and maintain case histories and other records for regulated clinical investigations or other regulated research. NOTE: Control is often used as a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare, maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2. CSUCT] See also record. Control of Electronic Records C142703 C67497 CDISC Glossary control A comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature, synthetic data)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol), synthetic data. Study Control C28279 C67497 CDISC Glossary controlled study A study in which a test article is compared with a treatment that has known effects (active control), no treatment, placebo, or dose comparison concurrent control, or external (historic) control. [21 CFR 314.126 and ICH E10]. See also control, comparator (product), control group. Controlled Study C48697 C67497 CDISC Glossary controlled vocabulary controlled terminology A finite set of values that represent the only allowed values for a data item. These values may be codes, text, or numeric. See also codelist. Controlled Vocabulary C142465 C67497 CDISC Glossary coordinating committee A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. [ICH E6] Coordinating Committee C51818 C67497 CDISC Glossary coordinating investigator An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. NOTE: Depending on the scope of the trial, coordination could be across centers/sites in a region, across regions, or within a nation. [ICH E6] See also investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator. Coordinating Investigator C48834 C67497 CDISC Glossary correlation The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson's correlation or spearman's Rho. NOTE: Correlation does not necessarily mean causation. [After Hyperstat Online Glossary; CDISC ADaM] Correlation C142645 C67497 CDISC Glossary covariate (prognostic) Factor or condition that influences outcome of a trial. [ADaM] Prognostic Covariate C142625 C67497 CDISC Glossary CRF (paper) Case report form in which the data items are linked by the physical properties of paper to particular pages. NOTE: Data are captured manually and any comments, notes, and signatures are also linked to those data items by writing or typescript on the paper pages. See also eCRF, case report form. Paper Case Report Form C142410 C67497 CDISC Glossary CRF data Subset of clinical trial data that are entered into fields on a case report form. Case Report Form Data C156634 C67497 CDISC Glossary criterion validation (COA) criterion validation (re COA) Establishing the extent to which the scores of a clinical outcome assessment instrument are related to a known gold standard measure of the same concept. For most COAs clinical outcome assessments (COAs), criterion validity cannot be measured because there is no gold standard. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation. Clinical Outcome Assessment Criterion Validation C165825 C67497 CDISC Glossary cross-labeled product An investigational drug, device, or biological product packaged separately that, according to its proposed labeling, is intended for use only with another investigational or approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect. NOTE: In the case where an approved product is combined with an investigational product, upon approval of the cross-labeled product the label of the previously approved product should be modified to reflect the combination status. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, co-packaged product. Cross-labeled Product C53310 C67497 CDISC Glossary cross-sectional study A study that measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period. [After British Medical Journal, Epidemiology for the uninitiated] See also observational study. Cross-Sectional Study C82637 C67497 CDISC Glossary crossover trial A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [After ICH E9] Crossover Study C49704 C67497 CDISC Glossary CTCAE (Common Terminology Criterion for Adverse Events) Standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. NOTE: CTCAE is often used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. [After NCI] Common Terminology Criteria for Adverse Events C70818 C67497 CDISC Glossary CUI (common unique identifier) A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms. Concept Unique Identifier C54631 C67497 CDISC Glossary curriculum vitae (CV) Document that outlines a person's educational and professional history. Curriculum Vitae C142469 C67497 CDISC Glossary data acquisition Capture of data into a structured, computerized format without a human-to-computer interface (i.e., from another measuring instrument or computerized source). Contrast with data entry, electronic data capture. Data Acquisition C142470 C67497 CDISC Glossary data capture The process of collecting and recording measures and assessments for a specific purpose. NOTE: Data are said to be captured when they are extracted as permanent records for use in a new context or created as a source document in that context. An example would be data that are manually copied or otherwise extracted from an EHR that are then transferred into a clinical trial database to be used for a clinical trial. [After Working with Data, Australian National Data Service, Accessed 4 Sept 2020; AFter FDA Guidance on Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry, July 2018] See also data entry, EDC (electronic data capture). Data Capture C115521 C67497 CDISC Glossary data clarification form A form used to query an investigator and collect feedback to resolve questions regarding data. Data Clarification Form C142471 C67497 CDISC Glossary data clarification Answer supplied by the investigator in response to a query. NOTE: The investigator may supply a new data point value to replace the initial value or a confirmation of the queried data point. Data Clarification C142472 C67497 CDISC Glossary data collection instruments Documents or tools which are used to collect, record or transcribe information on substantially identical items from a group of respondents. NOTE: Instruments can be either electronic or paper based tests, questionnaires, inventories, interview schedules or guides, rating scales, and survey plans or any other forms. [After 45 CFR 63.32] Data Collection Instrument C103159 C67497 CDISC Glossary data collection In the context of clinical research, accessing and recording information that provides source data for analysis and interpretation See data entry and data capture. [CDISC] Data Collection C142474 C67497 CDISC Glossary data element identifier An identifier that may include information such as the origin of the data element, the date and time of entry, or the identification number of the study subject to whom the data element applies. NOTE: Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. [After body and glossary of FDA Final Guidance eSource] Data Element Identifier C41002 C67497 CDISC Glossary data element Smallest unit of information in a transaction. [From body and glossary of FDA Final Guidance on eSource] See also eXtensible markup language (XML) data element, common data element, clinical study data element. Data Element C142475 C67497 CDISC Glossary data encryption standard (DES) A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. NOTE: Data that are considered sensitive by the responsible authority or data that represent a high value should be cryptographically protected if vulnerable to unauthorized disclosure or undetected modification during transmission or while in storage. [After Federal Information Processing Standards (FIPS) Publication 46-2] Data Encryption Standard C142379 C67497 CDISC Glossary data entry Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. Contrast with data acquisition, electronic data capture, direct entry. See also data collection, data capture. Data Entry C142477 C67497 CDISC Glossary data integrity verification Process of manually supervised verification of data for internal consistency. Data Integrity Verification C142476 C67497 CDISC Glossary data integrity A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on "GxP data integrity") See also ALCOA, ALCOA+, traceability (data). Compare to data quality. Data Integrity C142478 C67497 CDISC Glossary data interchange Transfer of information between two or more parties, which maintains the integrity of the contents of the data for the purpose intended. See also interoperability. Data Interchange C142479 C67497 CDISC Glossary data item A named component of a data element. Usually the smallest component [ANSI]. See also data model, data element. Data Item C142483 C67497 CDISC Glossary data listing Set of observations organized by domain. Data Listing C142484 C67497 CDISC Glossary data management conventions Procedures and policies for data management (e.g., documented procedure(s) for resolving self-evident changes). [ICH E6] See self-evident change. Data Management Convention C18086 C67497 CDISC Glossary data management Tasks associated with the entry, transfer, and/or preparation of source data and derived items for entry into a clinical trial database. NOTE: Data management could include database creation, data entry, review, coding, data editing, data QC, locking, or archiving; it typically does not include source data capture. Data Management C142487 C67497 CDISC Glossary data model Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use. A data model uses symbolic conventions agreed to represent content so that content does not lose its intended meaning when communicated. Data Model C142489 C67497 CDISC Glossary data monitoring committee (DMC) Data and Safety Monitoring Board; DSMB Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial. The DMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial. NOTE: A DMC can recommend stopping a trial if it finds toxicities or if treatment is proved beneficial. [After FDA guidance on establishment and operation of clinical trial data monitoring committees] Data Monitoring Committee C142488 C67497 CDISC Glossary data monitoring Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle. NOTE: Monitoring is undertaken by qualified study personnel following a specific process and auditable methods. See also ALCOA+ Data Monitoring C16493 C67497 CDISC Glossary data origin Source of information collected in the course of a clinical trial, specifically used to differentiate between data as collected versus data that are derived or calculated. NOTE: In CDISC, a metadata attribute defined for each dataset variable in the Define.xml document of an SDTM submission that refers to the source of a variable (e.g., CRF, derived, sponsor defined, PRO, etc.). See also data element originator. Data Source C142490 C67497 CDISC Glossary data originator Metadata characterizing the entity creating a data element in an eCRF for a clinical investigation. NOTE: Per FDA Final Guidance on eSource, "Each data element is associated with an origination type that identifies the source of its capture in the eCRF. This could be a person, a computer system, a device, or an instrument that is authorized to enter, change, or transmit data elements into the eCRF (also sometimes known as an author)." See also data element, data element originator, origin. [CDISC, Note is from FDA Final Guidance on eSource] Data Originator C142491 C67497 CDISC Glossary data quality A dimension of data contributing its trustworthiness and pertaining to accuracy, sensitivity, validity, and suitability to purpose. Key elements of data quality include attribution, legibility (decipherable, unambiguous), contemporaneousness, originality (i.e., not duplicated), accuracy, precision, completeness, consistency (logical, not out of range), and those who have modified the data. NOTE: Scientists may reasonably trust data that are accurate (high quality) that have also been reviewed by investigators and protected from unauthorized alteration (high integrity). See also ALCOA, data integrity. Data Quality C142492 C67497 CDISC Glossary data security Degree to which data are protected from the risk of accidental or malicious alteration or destruction and from unauthorized access or disclosure. [FDA] Data Security C142493 C67497 CDISC Glossary data selection criteria The rules by which particular data are selected and/ or transferred between the point of care and the patient record; subsequently, from the patient record to the database; and from database to inclusion in sub-population analyses. Data Selection Criteria C191275 C67497 CDISC Glossary data sharing Providing clinical trial data or access to data and final results to key stakeholders with the goal of increasing scientific knowledge and ultimately better therapies for patients. NOTE: guiding principles for data sharing: (1) maximize the benefits of clinical trials while minimizing the risks or harm of sharing clinical trial data, (2) respect individual participants whose data are shared, (3) increase public trust in clinical trials and the sharing of trial data, and (4) conduct the sharing of clinical trial data in a fair manner. [After National Academies of Sciences, Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press, 2015, accessed 2022-09-07] Clinical Data Sharing C103180 C67497 CDISC Glossary data standards Defined rules, conventions, guidelines, characteristics, methods, formats, and terminologies that provide structure and consistency for exchange and utilization of data. NOTE: Data standards may describe the elements and relationships necessary to achieve the unambiguous exchange of data between disparate information systems. [After https://www.fda.gov/media/124694/download Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry MARCH2019, NCI Thesaurus]. See also interoperability, standard, CDISC standards, Study Data Standardization Plan, and Standards Development Organization. Data Standard C142494 C67497 CDISC Glossary data storage To maintain data by placing the data, or a copy of the data, onto an electronically accessible device for preservation (either in plain-text or encrypted format). [HL7 eHR-s FM Glossary of Terms, 2010]. Data Storage C142495 C67497 CDISC Glossary data subject In the context of privacy guidelines, An individual who is the subject of personal data, persons to whom data refers, and from whom data are collected, processed, and stored. [after ISO/TS 2537:2008; and EU GDPR] See also study participant, participant. Data Subject C43582 C67497 CDISC Glossary data transformations Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis. [ADaM] See also derived variable. Data Transformation C42645 C67497 CDISC Glossary data type Data types define the structural format of the data carried in the attribute and influence the set of allowable values an attribute may assume. [HL7] Data Type C142500 C67497 CDISC Glossary data validation Process used to determine whether data are accurate, authentic, complete, and/or compliant with applicable standards, rules, and conventions. NOTE: The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [After FDA.; ISO] See also data integrity, validation. Data Validation C25474 C67497 CDISC Glossary data Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA] Data C142503 C67497 CDISC Glossary database lock Action taken to prevent further changes to a clinical trial database or any equivalent clinical data storage system. NOTE: Locking of a database is done after review, query resolution, and a determination has been made that the database is ready for analysis. Database Lock C15426 C67497 CDISC Glossary database A collection of data or information, typically organized for ease and speed of search and retrieval. Database C47824 C67497 CDISC Glossary dataset A collection of structured data in a single file. [CDISC] Compare to analysis dataset, tabulation dataset. Data Set C139171 C67497 CDISC Glossary date of first enrollment Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] Compare to study start date. Date of First Enrollment into Study C45970 C67497 CDISC Glossary de-identification The process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. NOTE: A general term for a process of removing the association between a set of identifying data and the data subject. Examples of potentially identifying data include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [After ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; HIPAA: 45 CFR, 164.514] See also anonymization. Deidentification C142507 C67497 CDISC Glossary de-identified information Records that have had enough personally identifiable information removed or obscured such that the remaining information does not identify an individual, and there is no reasonable basis to believe that the information can be used to identify an individual. [Guide to Protecting Personally Identifiable Information (PII): Special Publication NIST pubs/800-122] De-identified Information C176257 C67497 CDISC Glossary decentralized clinical trial (DCT) A trial in which data capture, administration of medication, and possibly other procedures are done at the subject's location, e.g., at home or by telemedicine, mobile technology, and local HCPs (like family physicians, general practitioners). NOTE: The procedures (entry of data, medical tests, clinical evaluations, objective measures, observations) for capturing safety and efficacy measurements and observations may be done in-person by a traveling clinician or nurse so DCTs are not necessarily virtual. The responsibility for preparation, maintenance and retention of source records may be allocated to a centralized investigator or sponsor investigator. [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also remote clinical trial, virtual, visit. Decentralized Clinical Trial C142504 C67497 CDISC Glossary decision rule Succinct statement of how a decision will be reached based upon the expected foreseen clinical benefits in terms of outcomes of the primary endpoint. [FDA documentation] Decision Rule C142505 C67497 CDISC Glossary Declaration of Helsinki A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. it was originally adopted by the 18th World Medical assembly (Helsinki, Finland, 1964) and recently revised (64th WMA General Assembly, Fortaleza, Brazil, October 2013). Declaration of Helsinki C176258 C67497 CDISC Glossary deep learning A subset of machine learning that is part of the broader family of machine learning methodologies based on artificial neural networks. A deep neural network has multiple layers between input and output layers to progressively extract higher level features from the raw input. [After DeepAI Machine Learning Glossary and Terms] See also machine learning, artificial intelligence (AI). Deep Learning C142506 C67497 CDISC Glossary Define-XML A table in XML that transmits metadata that describes any tabular dataset structure. NOTE: When used with the CDISC content standards, it provides the metadata for human and animal model tabular datasets such as SDTM, SEND, and ADaM. [After CDISC.org] See also eXtensible markup language (XML) data element, XML (eXtensible Markup Language). Define.xml C142508 C67497 CDISC Glossary demographic data Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating. Demographic Data C142509 C67497 CDISC Glossary dependent variable A variable that is expected to change as a result of an experiment. Dependent variables are influenced by independent variables. [After AMA Manual of Style] See also independent variable. Dependent Variable C142538 C67497 CDISC Glossary deployment Readying an electronic clinical trial system for field use by providing or disseminating capture devices, tokens, or passwords for users of an activated system. See activation. Electronic System Deployment C142510 C67497 CDISC Glossary derived variable New variable created as a function of existing variables and/or application of mathematical functions. See also variable, raw data. Derived Variable C142442 C67497 CDISC Glossary design configuration Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [After ICH E9] Clinical Trial Design Configuration C142443 C67497 CDISC Glossary development plan An ordered program of clinical trials, each with specific objectives. [adapted from ICH E9, see ICH E8]. See also clinical development plan. Clinical Trial Development Plan C15220 C67497 CDISC Glossary diagnosis A process to identify the disease or condition that explains the symptoms and signs occurring in a patient. NOTE: The information required for diagnosis is collected from a history and physical examination of the patient and preferably confirmed by one or more diagnostic procedures such as laboratory tests, radiologic studies and other technical investigations. [After "Making a diagnosis", John P. Langlois, Chapter 10 in Fundamentals of clinical practice (2002). Mark B. Mengel, Warren Lee Holleman, Scott A. Fields. 2nd edition.] See also treatment, intervention, disease, sign, symptom. Diagnosis C156648 C67497 CDISC Glossary DIBD (development international birth date) The sponsor's first authorization to conduct a clinical trial in any country worldwide. NOTE: Used to start the annual period for the Development Safety Update Report (DSUR). [After CIOMS VII; ICH E2F] Development International Birth Date C80447 C67497 CDISC Glossary digital signature An electronic signature, based on cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters, such that the identity of the signer and the integrity of the data can be verified. [21 CFR 11] Digital Signature C142511 C67497 CDISC Glossary direct access Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. NOTE: The party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. [ICH E6 Glossary] Direct Access C142512 C67497 CDISC Glossary direct entry Recording of data by human or automated action where an electronic record is the original means of capturing the data into an electronic records system without a paper source document. Examples are an individual keying original observations into a system or the automatic recording into the system of the output from measuring devices such as a balance that measures subject's body weight or an ECG machine. Compare to data entry, data acquisition. Direct Data Entry C142513 C67497 CDISC Glossary direct identifier A piece of data that can be used to uniquely identify an individual (e.g., name, patient ID, social security number, exact address, telephone number, e-mail address, government issued identifiers, passport/VISA numbers) either without additional information or with cross-linking through other information that is in the public domain. [After PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.] Direct Identifier C142444 C67497 CDISC Glossary discontinuation The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] See also withdrawal. Study Subject Discontinuation C142473 C67497 CDISC Glossary discrepancy The failure of a data point to pass a validation check. NOTE: Discrepancies may be detected by computerized edit checks or observed/ identified by the data reviewer as a result of manual data review. See also query. Data Discrepancy C2991 C67497 CDISC Glossary disease Any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the affected person. NOTE: The term is often used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function. [After NCI Thesaurus] See also diagnosis. Disease or Disorder C142571 C67497 CDISC Glossary document (HL7) An ordered presentation of XML elements, possibly including text and tabular analyses, description, and figures. Descriptors for HL7 documents include type, class, and element. NOTE: In HL7, a document can be either physical (referring to the paper) or logical (referring to the content) with the following characteristics: 1) Stewardship; 2) Potential for authentication; 3) Wholeness; 4) Human readability; 5) Persistence; 6) Global vs. local context. HL7 Document C142751 C67497 CDISC Glossary document root The element in an XML document that contains all other elements; the first element in the document. [SPL Glossary] XML Document Root C142515 C67497 CDISC Glossary document type definition (DTD) XML specification for content and presentation of data and text in a document including definitions for the elements considered to be legal in the document. NOTE: Agreeing on a common DTD facilitates interoperability among systems incorporating the agreed standards. [From Electronic Submission File Formats and Specifications. Orientation and Best Practices For Data Formats and Submission to The Center For Tobacco Products. January 2018; Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry. January 2019] Document Type Definition C19498 C67497 CDISC Glossary documentation All records, in any form (including but not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. [ICH E6 Glossary] Document C54076 C67497 CDISC Glossary domain name The way a particular web server is identified on the internet. For example, www.fda.gov names the World Wide Web (www) server for the Food and Drug administration, which is a government (.gov) entity. [Center for advancement of Clinical Research] Domain Name C62289 C67497 CDISC Glossary domain A collection of logically related observations with a common, specific topic that are normally collected for all subjects in a clinical investigation. NOTE: The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Example domains include laboratory test results (LB), adverse events (AE), concomitant medications (CM). [After SDTM Implementation Guide version 3.2, CDISC.org] See also general observation class. Domain C42636 C67497 CDISC Glossary dosage form dose form; pharmaceutical form Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally-but not necessarily-in association with one or more other ingredients. [21 CFR 314.3 and after IDMP]. See also drug product. Pharmaceutical Dosage Form C142516 C67497 CDISC Glossary dosage regimen The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style] Dosage Regimen C94394 C67497 CDISC Glossary dosage The amount of drug administered to a patient or test subject over a period of time; a regulated time bound administration of individual doses. NOTE: For example, a daily dosage specified in a prescription or a clinical trial, such as one 100mg tablet taken 4 times per day. [After AMA Manual of style] Cumulative Dose C142517 C67497 CDISC Glossary dose strength The strength of a drug product, which indicates the amount of each active ingredient in a single dose. For liquids, it is the proportion of each active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms] dose strength C25488 C67497 CDISC Glossary dose Specified quantity of a medicine, to be taken at one time or at stated intervals. [ISO 11615:2012 Health Informatics] Dose C90475 C67497 CDISC Glossary dose-escalation trial A study in which the dosage of the test article is increased until the desired physiological effect or toxicity is seen. (CDISC; After ICH E4) Titration Study C15228 C67497 CDISC Glossary double-blind study A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows the treatment a subject is receiving. [After FDA Glossary of Terms] Double Blind Study C142518 C67497 CDISC Glossary double-dummy A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. supplies are prepared for Treatment a (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). subjects then take two sets of treatment; either a (active) and B (placebo), or a (placebo) and B (active). [ICH E9] Double-Dummy C142445 C67497 CDISC Glossary dropout A subject in a clinical trial who for any reason fails to continue in the trial until the last visit or observation required of him/her by the study protocol. [from ICH E9] Clinical Trial Dropout C142519 C67497 CDISC Glossary drug development process The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies. Drug Development Process C79370 C67497 CDISC Glossary drug distribution In pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other tissues. See also ADME. Pharmacokinetics: Distribution C459 C67497 CDISC Glossary drug product A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21CFR210.3] See also medicinal product, dosage form. Medication C1909 C67497 CDISC Glossary drug An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)]. See also medicinal product, active substance. Pharmacologic Substance C142520 C67497 CDISC Glossary dynamic HTML Collective term for a combination of tags and options, style sheets, and programming that allows users to create web pages in hypertext Mark-up language (HTML) that are more responsive to user interaction than previous versions of HTML. Dynamic Hypertext Markup Language C184387 C67497 CDISC Glossary early termination of trial premature termination of trial The premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with. [REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC; ICH E6] See also termination (of a clinical trial). Early Termination of Trial C142525 C67497 CDISC Glossary eCertified copy A copy of an electronic record that is created through the application of a process validated to preserve the data and metadata of the original and where the validation of the process is certified by the dated signature of an authorized person. [CDISC, after EMA/INS/GCP/454280/2010 GCP Inspectors Working Group (GCP IWG) June 2010] Electronic Certified Copy C142526 C67497 CDISC Glossary eClinical trial eClinical investigation; eClinical study Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical study, clinical trial. Electronic Clinical Trial C142523 C67497 CDISC Glossary eCRF (electronic case report form) An auditable electronic record of information that is reported to the sponsor (or sponsor's agent such as an EDC provider) on each trial subject to enable data pertaining to a clinical investigation protocol to be systematically captured, reviewed, managed, stored, analyzed, and reported. The eCRF is a CRF in which related data items and their associated comments, notes, and signatures are linked programmatically. See also case report form, CRF, eSRF.[CSUICI; Revised from FDA Final Guidance on eSource] Electronic Case Report Form C142524 C67497 CDISC Glossary eCRT (electronic case report tabulation) Case report tabulation (CRT) provided in electronic format for eSubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. SDTM is the preferred format. Electronic Case Report Tabulation C142527 C67497 CDISC Glossary EDC (electronic data capture) The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] See also data entry, direct data entry, data acquisition, data capture. Electronic Data Capture C142521 C67497 CDISC Glossary edit check An auditable process, usually automated, of assessing the content of a data field against its expected logical, format, range, or other properties that is intended to reduce error. NOTE: Time-of-entry edit checks are a type of edit check that is run (executed) at the time data are first captured or transcribed to an electronic device at the time entry is completed of each field or group of fields on a form. Back-end edit checks are a type that is run against data that has been entered or captured electronically and has also been received by a centralized data store. Edit Check C156649 C67497 CDISC Glossary EDR (electronic document room) The electronic document room is an extension of the e-Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links. Electronic Document Room C18919 C67497 CDISC Glossary effect treatment effect An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments. [ICH E9] See also treatment effect. Outcome of Therapy C142522 C67497 CDISC Glossary effectiveness A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy. Effectiveness C88183 C67497 CDISC Glossary efficacy A measure of intended effect on the disease or condition based on adequate and well-controlled clinical trials. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also effectiveness. Efficacy C142529 C67497 CDISC Glossary EHR (electronic health record) An electronic record for healthcare providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards. NOTE: The EHR has the following distinguishing features: able to be obtained from multiple sources; shareable; interoperable; accessible to authorized parties. [After National Office of Health Information Technology-HIT, USHHS] Electronic Health Record C142530 C67497 CDISC Glossary electronic personal health record (ePHR) An electronic record for individuals to create, import, store, and use clinical information to support their own health. Electronic Personal Health Record C142531 C67497 CDISC Glossary electronic record Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. [21 CFR 11.3(b) (6)] Electronic Record C142533 C67497 CDISC Glossary electronic signature eSignature A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7)] Electronic Signature C16112 C67497 CDISC Glossary eligibility criteria Requirements that must be met for a person to be included in a study, which help make sure that the results of the study are caused by the intervention being tested and not by other factors. NOTE: Eligibility Criteria, including inclusion and exclusion criteria, should enable constitution of the targeted cohorts in the clinical study. [After NCI's Dictionary of Cancer Terms] Clinical Trial Eligibility Criteria C96966 C67497 CDISC Glossary emergency use authorization EUA Approval by FDA for the emergency use of certain unapproved medical products or an unapproved use of an approved medical product for certain emergency circumstances, when applied for under a declared health emergency. These medical products may be referred to as medical countermeasures (MCMs) and may include drugs, biologics, and devices. [After Emergency Use Authorization of Medical Products and Related Authorities. FDA Guidance for Industry and Other Stakeholders. January 2017.] See also pre-approval access. Emergency Use Authorization C45259 C67497 CDISC Glossary EMR (electronic medical record) An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs (or EHRs) may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11). [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] Electronic Medical Record C165826 C67497 CDISC Glossary end-point assessment medicinal product Medicinal products given to the subject as an aid to assess a relevant clinical trial end-point; it is not being tested or used as a reference in the clinical trial. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017] End-point Assessment Medicinal Product C171503 C67497 CDISC Glossary endemic disease The constant presence of a disease or infectious agent within a given geographic area or population group; may also refer to the usual prevalence of a given disease within such area or group. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001] Endemic Disorder C25212 C67497 CDISC Glossary endpoint A defined variable intended to reflect an outcome of interest to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. Primary endpoints are usually statistically analyzed. [After BEST Resource] See also outcome, variable, surrogate endpoint. End Point C142715 C67497 CDISC Glossary enrolled Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. A less common definition confers enrolled status at the signing of an informed consent form, e.g., Clinicaltrials.gov. See also informed consent, enrollment. Study Subject Enrolled C142466 C67497 CDISC Glossary enrollment (cumulative) Current enrollment including any subjects who were once enrolled and have ended participation. Cumulative Enrollment C142467 C67497 CDISC Glossary enrollment (current) Subjects actively continuing to participate in a clinical trial as of the current date. Current Enrollment C37948 C67497 CDISC Glossary enrollment The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. [After Glossary Of Terms On Clinical Trials For Patient Engagement Advisory Committee Meeting] See also enrolled. Enrollment C171452 C67497 CDISC Glossary epidemic The occurrence in a community or region of cases of an illness, specific health-related behavior, or other health-related events clearly in excess of normal expectancy. NOTE: The community or region and the period in which the cases occur are specified precisely. The number of cases indicating the presence of an epidemic varies according to the agent, size, and type of population exposed; previous experience or lack of exposure to the disease; and time and place of occurrence. [After A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, OXFORD UNIVERSITY PRESS 2001] Epidemic Disorder C71738 C67497 CDISC Glossary epoch Planned interval of time in the conduct of a study wherein an activity is specified and consistent, e.g., specific treatment dose or study activity such as Screening. NOTE: A CDISC variable used in the SDTM model to indicate a time period defined in the protocol with a study-specific purpose. See also arm, visit, phase (within a study). Clinical Trial Epoch C137811 C67497 CDISC Glossary ePRO Patient reported outcome data initially captured electronically. NOTE: Usually ePRO data is captured as eSource. [DIA ePRO Working Group]. See also patient reported outcome, PRO, eSource. Electronic Patient-reported Outcome System C142428 C67497 CDISC Glossary equipoise A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. NOTE: An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial. Clinical Equipoise C142539 C67497 CDISC Glossary equivalence trial A trial with the primary objective of showing that the response to two or more treatments differs by an amount that is clinically unimportant. NOTE: This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. Equivalence Trial C142534 C67497 CDISC Glossary eSource data Source data captured initially into a permanent electronic record (eSource document) used for the reconstruction and evaluation of a clinical study or a source data item included in an eCRF when direct entry is made. NOTE: permanent in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail. See also eSource document, source data, permanent data, data originator. [From body of FDA Final Guidance on eSource] Electronic Source Data C142535 C67497 CDISC Glossary eSource document Electronic record containing source data for a clinical trial, used to aggregate a particular instance of eSource data items for capture, transmission, storage, and/ or display, and serving as a source document for a clinical investigation. NOTE: Electronic Source documents are recorded in electronic systems according to conventions (such as those for PDF documents) that ensure that all the fields of eSource data and associated contextual information (e.g. time of capture, time zone, authorship, origin, signatures, revisions, etc.) are linked to each other in a particular structure for presentation. The encoded specifications in the electronic record thus serve the same role as have the physical properties of paper (binding data items together). eSource documents are subject to regulations and guidance that apply to source documents. See also source documents. [relevant to FDA Final Guidance on eSource] Electronic Source Document C142536 C67497 CDISC Glossary eSource Source record that is electronic. See also source, electronic record. Electronic Source Record C142537 C67497 CDISC Glossary eSRF (electronic source report form) The human-readable rendering of an electronic record serving as an eSource document that is part of a case history. The eSRF supports capture, transmission, storage, editing and/ or display of eSource documents (original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation) used for reconstructing and evaluating the investigation. NOTE: Intended use distinguishes eCRF and eSRF. The eCRF is for capture, review and editing of protocol data belonging to the sponsor; the eSRF is for the human-readable representation of the eSource document for review or to maintain the eSource document that is part of the case history under 21CFR312.62. See also eCRF, eSource document. [CDISC, relevant to FDA Final Guidance on eSource] Electronic Source Report Form C142540 C67497 CDISC Glossary essential documents Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. [ICH E6 Glossary] Essential Trial Document C97104 C67497 CDISC Glossary established name The official name of a drug or pharmaceutical product, relevant in US regulations. [US FDA, 21 CFR 299.4] See also proprietary name, generic name, international nonproprietary name (INN), medicinal product name, compendial name. Established Drug Name C188813 C67497 CDISC Glossary estimand A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarizes at a population level what the outcomes would be in the same patients under different treatment conditions being compared. NOTE: The four characteristics of an estimand include the definition of the target study population, statement of the endpoint of interest, intercurrent event details, and the population level summary of the variable of interest. (ICH E9 R1 Addendum; After Estimand Framework: What it is and Why You Need it. Applied Clinical Trials. February 27, 2020] Estimand C142541 C67497 CDISC Glossary ethics committee Group convened to protect research subjects. NOTE: Such bodies, depending on the country or region, are abbreviated as: CCI, CCPPRB, CHR, CPPHS, CRB, EAB, HEX, HSRC, LREC, MREC, NIRB, NRB, and REB. See also institutional review board, independent ethics committee. Ethics Committee C16564 C67497 CDISC Glossary ethnicity Denotes social groups with a shared history, sense of identity, geography, and cultural roots. Ethnic Group C142543 C67497 CDISC Glossary European Medicines Agency (EMA) The regulatory agency for the EU. European Medicines Agency C142546 C67497 CDISC Glossary evaluable (for efficacy and safety) Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in efficacy/safety datasets. Evaluable for Safety and Efficacy C74589 C67497 CDISC Glossary event Planned protocol activities such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). [After SDTM, www.cdisc.org] See also general observation class, intervention, finding. Protocol Event C25370 C67497 CDISC Glossary exclusion criteria List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. Exclusion Criteria C94618 C67497 CDISC Glossary excretion The act or process of eliminating waste products from the body. See also ADME. Excretion C191276 C67497 CDISC Glossary expansion cohort trial A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022] Expansion Cohort Trial C41161 C67497 CDISC Glossary experimental intervention Study Treatment; Target Product; Test Article The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). NOTE: This does not include comparators or placebos. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224; https://grants.nih.gov/policy/clinical-trials/protocol-template.htm] See also test articles, devices, drug product, combination product, treatment, diagnosis, investigational medicinal product. Protocol Agent C93388 C67497 CDISC Glossary experimental unit A physical entity which is the primary interest in a specific research objective. NOTE: Depending on the research objectives, a single study may have multiple levels of experimental units. Commonly the individual study subject (animal, person or product) is the experimental unit. (BRIDG v5.3) Experimental Unit C142547 C67497 CDISC Glossary exploratory IND study A clinical study that is conducted early in Phase 1; involves very limited human exposure and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [FDA Guidance for industry, investigators, and Reviewers: exploratory IND studies, January 2006] See also Phase 0. Exploratory Investigational New Drug Study C39538 C67497 CDISC Glossary exploratory study Phase 1 or 2 study during which the actions of a therapeutic intervention are assessed and measured. NOTE: Procedures in exploratory studies may appropriately be altered beyond the standard adequate and well controlled processes to expand the scope or method of investigation. [NOTE: After FDA eCOA Glossary] Compare to confirmatory study. Therapeutic Exploratory Study C156623 C67497 CDISC Glossary exposure (individual) The result of an intentional contact (e.g., intervention, dosage, drug/product use, misuse, or abuse) or an unintentional contact (circumstantial events leading to unknown, inadvertent, or accidental contact) resulting in inputs to the body of an individual which can occur directly through primary bodily contact routes or indirectly through secondary contact routes (such as via fluids as in fetal exposure during pregnancy or lactation/breast feeding or other biological transfers). [After FDA, Reviewer Guidance Evaluating the Risks of Drug Exposure in Human Pregnancies] See also exposure, intervention, extent of exposure. Individual Exposure C17941 C67497 CDISC Glossary exposure Contact between an agent and a target. A state of contact or close proximity to a medicinal product, chemical, pathogen, radioisotope or other substance. NOTE: Types of exposure may be described by many qualifiers (e.g., local, systemic, acute, chronic, cumulative, environmental, population, individual, gestational, or occupational.) See also exposure (individual), intervention, extent of exposure. [After International Programme on Chemical Safety (IPCS) 2004 WHO] Exposure C142548 C67497 CDISC Glossary eXtensible markup language (XML) data element For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019] See also XML (eXtensible Markup Language), Define-XML. Extensible Markup Language Data Element C156624 C67497 CDISC Glossary extent of exposure A variable of exposure taking into consideration the strength, dose, duration, frequency, route, and/or timing or gestational stage in utero and other factors. NOTE: Measures of concentrations in biological fluids and tissues may be used to attempt to quantify the extent of exposures (e.g., Cmax, Cmin, Css, AUC in pharmacokinetics or other exposure measurement and assessment models). [After, FDA Guidance for Industry Exposure-Response Relationships] See also exposure, exposure (individual), intervention. Extent of Exposure C142549 C67497 CDISC Glossary extraction transformation load (ETL) A class of software applications for data extraction, transformation, and loading that are used to implement data interfaces between disparate database systems, often to populate data warehouses. Extraction Transformation Load C142557 C67497 CDISC Glossary feels A patient's physical sensation (e.g., symptoms) or perceived mental state. A patient may feel pain, feel feverish, or perceive a severely low mood (as with depression). [FDA Clinical Outcome Assessment (COA) Glossary] Feels C25507 C67497 CDISC Glossary field Locus on a data collection instrument (usually a CRF) for recording or displaying a data element. See data item. Data Field C100047 C67497 CDISC Glossary File Transfer Protocol (FTP) A standard protocol for exchanging files between computers on the internet. See also TCP/IP. File Transfer Protocol C115575 C67497 CDISC Glossary final report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. [ICH E3] Clinical Trial Final Report C3367 C67497 CDISC Glossary finding A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event. Finding C142558 C67497 CDISC Glossary first subject in - date, time (FSI - date, time) first patient in - date, time; FPI - date, time The date and/or date and time the first subject is enrolled into a study. See also enrollment. First Subject In Date Time C142559 C67497 CDISC Glossary first subject in - identity (FSI - identity) first patient in - identity; FPI - identity The first subject enrolled. See also enrollment. First Subject In Identity C142560 C67497 CDISC Glossary first subject screened - date, time first patient screened - date, time The date and/or date and time the first subject signs the informed consent form and is screened for potential enrollment or randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial. First Subject Screened Date Time C142561 C67497 CDISC Glossary first subject screened - identity first patient screened - identity The first subject who is so screened. First Subject Screened Identity C142562 C67497 CDISC Glossary first subject treated - date, time first patient treated - date, time The date and/or date and time when the first subject receives the test article or placebo in a clinical investigation. First Subject Treated Date Time C142563 C67497 CDISC Glossary first subject treated - identity first patient treated - identity The first subject who is so treated. First Subject Treated Identity C142564 C67497 CDISC Glossary first-in-humans study first-in-man study The first Phase 1 study in which the test product is administered to human beings. First-in-Human Study C156841 C67497 CDISC Glossary follow-up (clinical study) A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded. [CDISC SDTM Terminology] See also long term follow-up (clinical study). Follow-Up Period C17237 C67497 CDISC Glossary Food and Drug Administration (FDA) The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals. Food and Drug Administration C19464 C67497 CDISC Glossary Form A collection of items and item groups for capturing and displaying clinical trial data. Form C142565 C67497 CDISC Glossary frequentist methods Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation. [ICH E9] Frequentist Method C142502 C67497 CDISC Glossary frozen Status of a database, file, or element that has been presumed to be in its final state pending "lock" and where further editing is prevented without "unfreezing." NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from "locking" and "unlocking" only in the degree of approval required. See database lock. Database Frozen C142438 C67497 CDISC Glossary functional roles (in a study) The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. [HL7] Clinical Study Functional Role C142468 C67497 CDISC Glossary functions functioning The manner in which a patient can perform successfully tasks and roles required for everyday living. A patient's ability to perform specified activities that are a meaningful (to the patient), part of typical (e.g., daily) life. [FDA Clinical Outcome Assessment (COA) Glossary] Daily Living C17357 C67497 CDISC Glossary gender Subject self-identification re: masculine/feminine. [IOM] See also sex. Gender C15238 C67497 CDISC Glossary gene therapy Therapy based on ex vivo or in vivo gene modification of cells using specific technologies, e.g., viral vectors and direct genome editing technologies. NOTE: A particular example of this is the therapy with gene-modified T cells (chimeric antigen receptor (CAR) T-cell therapies) used as immunotherapy in oncology. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017.] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product. Gene Therapy C165827 C67497 CDISC Glossary general observation class In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level observation domains. NOTE: Most CDISC domains are assigned to one of three general observation classes: 1) The Interventions general observation class is a domain that captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (usually for therapeutic purposes) either as specified by the study protocol (e.g., exposure), coincident with the study assessment period (e.g., concomitant medications), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). 2) The Events general observation class captures occurrences or incidents independent of planned study evaluations occurring during the trial (e.g., "adverse events" or "disposition") or prior to the trial (e.g., "medical history"). 3) The Findings general observation class captures the observations resulting from planned evaluations such as observations made during a physical examination, laboratory tests, ECG testing, and sets of individual questions listed on questionnaires. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, event, intervention, finding. Compare with special purpose domain. CDISC General Observation Class C142429 C67497 CDISC Glossary generalizability The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings. [ICH E9] Clinical Generalizability C97054 C67497 CDISC Glossary generic name Nonproprietary Name The name of a drug based on its chemical and molecular structure. NOTE: In the United States of America, this is assigned by the United States Adopted Names (USAN) council. [After Merck Manual, Consumer Version, 2023] See also proprietary name, international nonproprietary name (INN), established name, medicinal product name, compendial name. Generic Name C142566 C67497 CDISC Glossary global assessment variable A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. [ICH E9] Global Assessment Variable C18232 C67497 CDISC Glossary glossary A collection of specialized words or terms with their meanings. Glossary C94236 C67497 CDISC Glossary Good Clinical Practice (GCP) GCRP; good clinical research practice A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. NOTE: For Guidance on Good Clinical Practice see COMP/ICH/135/95; Declaration of Helsinki; 21 CFR 50, 21 CFR 54, 21 CFR 56, and 21 CFR 312. [ICH] Good Clinical Practice C142567 C67497 CDISC Glossary granularity Refers to the size of an information unit in relation to a whole. NOTE: Structuring "privileges" in electronic systems is said to be highly granular when each of many roles can differ in their capacity to act on electronic records. Granularity C142568 C67497 CDISC Glossary group sequential design A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests. [Center for Advancement of Clinical Research] Group Sequential Design C142569 C67497 CDISC Glossary handwritten signature The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. NOTE: The act of signing with a writing or marking instrument such as a pen or stylus is preserved. [21CFR 11] Handwritten Signature C142542 C67497 CDISC Glossary harmonized standard A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC). European Harmonized Standard C80485 C67497 CDISC Glossary Health Level 7 (HL7) An ANSI-accredited Standards Developing Organization (SDO) operating in the healthcare arena. NOTE: Level 7 refers to the highest level of the International Standards Organization's (ISO) communications model for Open Systems Interconnection (OSI), the application level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. Level 7 supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations, and, most importantly, data exchange structuring. Health Level Seven C176259 C67497 CDISC Glossary health literacy The degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make health decisions. [After The Patient Protection and Affordable Care Act of 2010, Title V; After What is Health Literacy? Oct 23, 2019]. See also plain language writing. Health Literacy C142570 C67497 CDISC Glossary health-related quality of life (HRQoL) A multi-domain concept that represents the patient's general perception of the effect of illness and treatment on physical, psychological, and social aspects of life. NOTE: Claiming a statistical and meaningful improvement in HRQoL implies: (1) that all HRQoL domains that are important to interpreting change in how the clinical trial's population feels or functions as a result of the targeted disease and its treatment were measured; (2) that a general improvement was demonstrated; and (3) that no decrement was demonstrated in any domain. [FDA Clinical Outcome Assessment (COA) Glossary] Compare to quality of life (QoL). Health-related Quality of Life C16666 C67497 CDISC Glossary healthcare provider A person licensed, certified, or otherwise authorized or permitted by law to administer healthcare in the ordinary course of business or practice of a profession, including a healthcare facility. [HL7] Health Care Provider C49651 C67497 CDISC Glossary healthy volunteer A healthy person volunteering to participate as a subject in a clinical study. NOTE: This is often a healthy person agreeing to participate in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 03/30/2023] Healthy Subject C156650 C67497 CDISC Glossary HIE (Health Information Exchange) The mobilization of healthcare information electronically across organizations within a region or community. HIE provides the capability to electronically move clinical information between disparate healthcare information systems, while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to, and retrieval of, clinical data to provide safer, more timely, efficient, effective, equitable, and patient-centered care. [HITSP] Health Information Exchange C70665 C67497 CDISC Glossary human subject subject/trial subject Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3]. See also clinical research subject. Human Study Subject C142572 C67497 CDISC Glossary Huriet Law France's regulations covering the initiation and conduct of clinical trials. Huriet Law C142380 C67497 CDISC Glossary HyperText Markup Language (HTML) A specification of the W3C that provides markup of documents for display in a web browser. [HL7] Contrast to XML. Hypertext Markup Language C142573 C67497 CDISC Glossary hypertext Links in a document that permit browsers to jump immediately to another document. NOTE: In most browsers links are displayed as colored, underlined text. Hypertext C142574 C67497 CDISC Glossary hypothesis to test In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value. [CONSORT Statement] Hypothesis To Test C171511 C67497 CDISC Glossary immediately life-threatening disease or condition A stage of disease in which there is reasonable likelihood that death will occur within a matter of months, or in which premature death is likely without early treatment. [21 CFR 312.300] Immediately Life-Threatening Disorder C142577 C67497 CDISC Glossary impartial witness A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. [ICH] Impartial Witness C53348 C67497 CDISC Glossary incidence rate A proportion calculated as the number of individuals who develop the disease during a period of time divided by the number of persons at risk. [After AMA Style Guide, 10th Edition; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] See also morbidity rate, morbidity, mortality, incidence, prevalence. Incidence Rate C16726 C67497 CDISC Glossary incidence The occurrence of new cases of disease, injury, or disability in a defined population over a specified period of time. NOTE: Incidence is most often expressed relative to the total population at risk (i.e., per unit of population). [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to prevalence. See also morbidity rate, morbidity, mortality, incidence rate. Incidence C25532 C67497 CDISC Glossary inclusion criteria The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. Inclusion Criteria C142578 C67497 CDISC Glossary independent data monitoring committee (IDMC) A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. [ICH E9] See also data monitoring committee. Independent Data Monitoring Committee C142579 C67497 CDISC Glossary independent ethics committee (IEC) An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [After ICH E6 R2 Glossary] See also institutional review board, ethics committee. Independent Ethics Committee C191277 C67497 CDISC Glossary independent variable A variable that is not affected by other variables that the study is trying to understand. Independent variables influence dependent variables. [After AMA Manual of Style] See also dependent variable. Independent Variable C41184 C67497 CDISC Glossary indication A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. NOTE: Where such a benefit has been established and approved by regulatory authorities, the therapy is said to be approved for such an indication. Indication C142581 C67497 CDISC Glossary indirect identifier quasi identifer Data which in connection with other information can be used to identify an individual with high probability, e.g., age at baseline, race, gender, events, specific findings, etc. NOTE: two levels of indirect identifier are distinguished. Level 1 - not likely to change over time, is visible, and is available in other sources. Typically it is demographic data such as sex, age at a particular date, country, body mass index (BMI). Level 2 - longitudinal information that is likely to change such as measurements, events, age. See also quasi identifier. [PhUSE De-identification Standard for SDTM 3.2, version 1.0.1.] Indirect Identifier C16735 C67497 CDISC Glossary informed consent An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form may include any "language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence." In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. See also consent form. Informed Consent C15388 C67497 CDISC Glossary infusion Any form of treatment that is introduced into the body slowly by constant administration or drip via a blood vessel, a muscle, or the spinal cord. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also administration (substance). Infusion Procedure C202575 C67497 CDISC Glossary ingredient Active and/or inactive material used in pharmaceutical product. [After ISO 11615:2017, 3.1.28] Pharmaceutical Product Ingredient C142448 C67497 CDISC Glossary inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). [ICH] See also audit. Clinical Trial Inspection C21541 C67497 CDISC Glossary institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH] Healthcare Facility C16741 C67497 CDISC Glossary institutional review board (IRB) committee for the protection of human subjects; independent ethics committee; independent review board An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. [ICH E6 1.31] Institutional Review Board C142631 C67497 CDISC Glossary instrument A means to capture data (e.g., questionnaire, diary) plus all the information and documentation that supports its use. NOTE: Generally, instruments include clearly defined methods and instructions for administration or responding, a standard format for data collection, and well-documented methods for scoring, analysis, and interpretation of results. [from PRO Draft Guidance] Compare to questionnaire, survey (see Comments on Draft PRO Guidance, April 4, 2006, by ISOQOL, p. 8). Patient-Reported Survey Instrument C54390 C67497 CDISC Glossary intended use The specific clinical circumstance or purpose for which a medical product or test is being developed. NOTE: In the regulatory context, this term refers to the "Statement of Intended Use" prepared by the persons legally responsible for the labeling of medical products. [after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] Medical Product or Procedure Intent of Use C54398 C67497 CDISC Glossary intention-to-treat The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given. NOTE: This has the consequence that subjects allocated to a treatment group should be followed up, assessed, and analyzed as members of that group irrespective of their compliance with the planned course of treatment. The principle is intended to prevent bias caused by loss of participants that may reflect non-adherence to the protocol and disrupt baseline equivalence established by random assignment. [ICH E9; after CONSORT statement] Intent To Treat C78688 C67497 CDISC Glossary inter-rater reliability The property of scales yielding equivalent results when used by different raters on different occasions. [ICH E9] Inter-rater Reliability C142732 C67497 CDISC Glossary interaction (qualitative and quantitative) The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (e.g., center). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction, the direction of the contrast differs for at least one level of the factor. [ICH E9 Glossary] Treatment Contrast Interaction C188815 C67497 CDISC Glossary intercurrent event An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. [ICH E9 Addendum on Estimands] Intercurrent Event C142583 C67497 CDISC Glossary interim analysis schedule The time/information points at which interim analyses are planned. Interim Analysis Schedule C142582 C67497 CDISC Glossary interim analysis(es) Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete. [CONSORT statement] Interim Analysis C115555 C67497 CDISC Glossary interim clinical trial/study report A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH] Interim Analysis Output C78687 C67497 CDISC Glossary internal consistency Pertaining to data that do not include contradictions. Internal Consistency C142584 C67497 CDISC Glossary international birth date (IBD) The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A] International Marketing Authorization Birth Date C142585 C67497 CDISC Glossary international nonproprietary name (INN) Unique name for a drug substance (pharmaceutical ingredient) that is globally recognized and public property. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO, Health products policy and standards, INN and medicines classification] See also proprietary name, generic name, established name, medicinal product name, compendial name, active substance. International Nonproprietary Name C142586 C67497 CDISC Glossary internet service provider (ISP) A company that provides access to the internet for individuals and organizations. Internet Service Provider C20342 C67497 CDISC Glossary internet A global system of computer networks that provides the common TCP IP infrastructure for e-mail, the World Wide Web, and other online activities. Internet C142381 C67497 CDISC Glossary interoperability Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic, semantic interoperability. Interoperability C25218 C67497 CDISC Glossary intervention An activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. This is a general term that encompasses the medical, social, behavioral, and environmental acts that can have preventive, therapeutic, or palliative effects. (NCI) See also investigational product, experimental intervention, vaccine, medical device, diagnostic device. Intervention or Procedure C72968 C67497 CDISC Glossary investigational device A device that is assessed in a clinical investigation. [REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] See also investigational product, medical device. Investigational Medical Device C202579 C67497 CDISC Glossary investigational medicinal product Investigational Product A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Reference products and placebos are also considered investigational medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP) -- Step 4 (final), 9 November 2016 -- Glossary] See also authorised investigational medicinal product, experimental intervention. Investigational Medicinal Product C25936 C67497 CDISC Glossary investigator An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team). [21 CFR 50.3] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator. Investigator C79303 C67497 CDISC Glossary investigator's brochure A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects. Investigational Brochure C142591 C67497 CDISC Glossary investigator/institution An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements" with respect to the transfer or assignment of responsibilities. [After ICH E6 1.35] See also coordinating investigator, investigator, principal investigator, site investigator, sponsor-investigator, sub-investigator. Investigator/Institution C142629 C67497 CDISC Glossary item (PRO) An individual question, statement, or task (and its standardized response options) that is evaluated by the patient to address a particular concept. [FDA Clinical Outcome Assessment (COA) Glossary] See also item generation, response option. Patient-reported Outcome Item C142592 C67497 CDISC Glossary item definition Formal specification of the properties of an item or field of data in an eClinical trial. [CDISC ODM, CDISC CDASH] Item Definition C142630 C67497 CDISC Glossary item generation Establishing the content to be covered by the items in a PRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and readability. NOTE: PRO instrument item generation is potentially incomplete without patient involvement. [from ISOQOL comments on PRO Draft Guidance] Patient-Reported Outcome Item Generation C142593 C67497 CDISC Glossary item group definition The specification in an eClinical trial of a collection of items often clinically related to each other and useful to consider as an ensemble. NOTE: Item groups are likely to have greater granularity in analysis datasets using SDTM which can, for example, distinguish between different therapy types: study therapy, prior therapy, concomitant therapy, protocol forbidden therapies, rescue therapies. [ODM] Item Group Definition C142431 C67497 CDISC Glossary item A representation of a clinical variable, fact, concept, or instruction in a manner suitable for communication, interpretation, or processing by humans or by automated means. NOTE: Items are collected together to form item groups. [CDISC] Compare to data item, item (PRO). Clinical Item C142594 C67497 CDISC Glossary Janus conceptual model A logical design for a data warehouse intended to integrate submission data, protocol descriptions, and analysis plans from clinical and animal studies into an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining, and retrospective comparative analysis. [FDA Study Data Standards] Janus Clinical Trials Repository Model C142595 C67497 CDISC Glossary Janus study data repository The Janus is a data repository for subject-level clinical and nonclinical study data submitted to FDA as part of a regulatory submission. NOTE: Sometimes written as JANUS, the term is not an acronym. [FDA Study Data Standards] Janus Study Data Repository C41203 C67497 CDISC Glossary label package insert, patient package leaflet Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL] Medical Product Label C54694 C67497 CDISC Glossary labeling (content of) All text, tables, and figures in labeling as described in regulations for a specific product (e.g., 21 CFR 201.56 and 201.57 for human prescription drugs; 201.66 for human over-the-counter drugs; 21 CFR 801 for medical devices; and 21 CFR 606.122 for blood products). See also structured product label. Labeling C142432 C67497 CDISC Glossary laboratory (clinical) A laboratory providing analyses of samples collected in clinical care or research. Clinical Laboratory C142596 C67497 CDISC Glossary last subject in - date, time (LSI - date, time) last patient in - date, time; LPI - date, time The date and/or date and time when a last subject to participate in a clinical trial is enrolled. Last Subject In Date Time C142597 C67497 CDISC Glossary last subject in - identity (LSI - identity) last patient in - identity; LPI - identity The last subject enrolled in a clinical trial. Last Subject In Identity C142598 C67497 CDISC Glossary last subject last visit - date, time (LSLV - date, time) last subject out/complete (LSC/LPC or LSO/LPO) - date, time) The date and/or date and time when a last subject has reached a planned or achieved milestone representing the completion of the trial. Last Subject Last Visit Date Time C142599 C67497 CDISC Glossary last subject last visit - identity (LSLV - identity) last subject complete - identity; last subject out - identity; LPC-dentity; LPO - identity; LSC - identity; LSO - identity The last subject to reach a planned or achieved milestone representing the completion of the trial. Last Subject Last Visit Identity C142514 C67497 CDISC Glossary legal authentication A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document. [HL7] Document Legally Authenticated C142600 C67497 CDISC Glossary legally acceptable representative An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. [ICH, E6 Glossary] Legally Acceptable Representative C84266 C67497 CDISC Glossary life-threatening adverse event/ experience Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred (i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death). [FDA 21 CFR 312.32; ICH-E2A] Life Threatening Adverse Event C16032 C67497 CDISC Glossary long term follow-up (clinical study) LTFU Planned observations that are made over an extended period of time and are a formal phase of a clinical study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study). Long-term Follow-up C15273 C67497 CDISC Glossary longitudinal study Investigation in which data are collected from a number of subjects over a long period of time (a well-known example is the Framingham study). Longitudinal Study C142601 C67497 CDISC Glossary low-interventional clinical trial A clinical trial which fulfills all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorized; (b) according to the protocol of the clinical trial, (i) the investigational medicinal products are used in accordance with the terms of the marketing authorization; or (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)] Low-interventional Clinical Trial C176231 C67497 CDISC Glossary machine learning A computing system (inspired by biological neural networks) that learns (progressively improves its ability) to do tasks by considering examples without task-specific programming. NOTE: Machine learning algorithms build a mathematical model based on sample data, known as "training data", in order to make predictions or decisions without being explicitly programmed to do so. It is a subset of artificial intelligence. [After DeepAI Machine Learning Glossary and Terms] See also deep learning, artificial intelligence (AI). Machine Learning C156625 C67497 CDISC Glossary manufacturer (device) Any person or entity who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either (1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture; (2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; (3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or (4) Is the U.S. agent of a foreign manufacturer. [after 21 CFR 803.3, FDA] See also manufacturer (drug). Device Manufacture C156626 C67497 CDISC Glossary manufacturer (drug) Any person or entity involved in the processing, packing, or holding of a medicinal product, including packaging and labeling, testing, and quality control. [after 21 CFR 210.3] See also manufacturer (device). Drug Manufacturer C142485 C67497 CDISC Glossary mapping In the context of representing or exchanging data, connecting an item or symbol to a code or concept. Compare to translation. Data Mapping C88074 C67497 CDISC Glossary marketing authorization holder Organization or person that is permitted to market a medicinal product in a jurisdiction. [After ISO 11615:2017, 3.1.41] Marketing Authorization Holder C142602 C67497 CDISC Glossary marketing authorization procedure Formal EU procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43] Marketing Authorization Procedure C156642 C67497 CDISC Glossary marketing authorization marketing approval Authorisation issued from a medicines regulatory agency that allows a Medicinal Product to be placed on the market. [after ISO 11615 2017-10 on Regulated Medicinal Product information] Marketing Authorization C142603 C67497 CDISC Glossary marketing support trials Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another. Marketing Support Trials C63615 C67497 CDISC Glossary markup Computer-processable annotations within a multimedia document. NOTE: in the context of the HL7 specification, markup syntax is according to the XML specification. [HL7] Markup C191278 C67497 CDISC Glossary masking The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from the comparator. NOTE: Blinding refers to study participants while masking refers to the study intervention. [After Crisp A. Blinding in pharmaceutical clinical trials: An overview of points to consider. Contemp Clin Trials. 2015;43:155-163.] See also blinding. Masking C165770 C67497 CDISC Glossary master protocol A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also umbrella trial design, basket trial design, platform trial design, adaptive design. Master Protocol C142604 C67497 CDISC Glossary matched-pair design A type of parallel trial design in which investigators identify pairs of subjects who are 'identical' with respect to relevant factors, then randomize them so that one receives Treatment a and the other Treatment B. See also pairing. Matched-Pair Design C53319 C67497 CDISC Glossary mean The sum of the values of all observations or data points divided by the number of observations; an arithmetical average. Arithmetic Mean C43820 C67497 CDISC Glossary MedDRA (Medical Dictionary for Regulatory Activities) A global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others. MedDRA C28007 C67497 CDISC Glossary median The middle value in a data set; that is, just as many values are greater than the median and lower than the median value. (With an even number of values, the conventional median is halfway between the two middle values.) Median C171514 C67497 CDISC Glossary medical countermeasure Pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and nonpharmaceutical products, such as ventilators, diagnostic tests, personal protective equipment (PPE), and patient (also general) decontamination materials, that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency. [After National Health Security Strategy 2019-2022] Medical Countermeasure C16830 C67497 CDISC Glossary medical device Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps] Medical Device C51836 C67497 CDISC Glossary medical monitor A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial. Medical Monitor C53607 C67497 CDISC Glossary medical monitoring Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose. See also monitoring. Patient Monitoring C156627 C67497 CDISC Glossary medication error Any unintentional error in the prescribing, dispensing or administration of a medicinal product while in the control of the healthcare professional, patient or consumer. [HMA, Guideline on good pharmacovigilance practices (GVP)] Medication Error C156643 C67497 CDISC Glossary medicinal product classification Categorisation or grouping of Medicinal Products based on specific properties and according to various classification systems (e.g., UNII-SRS), which may be regional or international. NOTE: The classification system is specified using an appropriate identification system; the applicable controlled term and the controlled term identifier is specified. [after ISO 11615 2017-10 on Regulated Medicinal Product information] Medicinal Product Classification C142606 C67497 CDISC Glossary medicinal product identifier Unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a jurisdiction. NOTE: proposed by IDMP as a new universal identifier. [After ISO 11615:2017, 3.1.53] Medicinal Product Identifier C142607 C67497 CDISC Glossary medicinal product name Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name. Medicinal Product Name C142605 C67497 CDISC Glossary medicinal product Any substance or combination of substances that may be administered to human beings (or animals) for treating or preventing disease, or with the intent to make a medical diagnosis or to restore, correct or modify physiological functions. NOTE: 1. A Medicinal Product may contain one or more manufactured items and one or more pharmaceutical products. 2. In certain jurisdictions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis. [After IDMP] Medicinal Product C142608 C67497 CDISC Glossary Medicines and Healthcare products Regulatory agency (MHRA) The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. [MHRA] Medicines And Healthcare Products Regulatory Agency C142609 C67497 CDISC Glossary mega-trials large sample trial Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects. Mega-Trial C142553 C67497 CDISC Glossary memorandum of understanding (MOU) A formal agreement between the Food and Drug administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities. NOTE: The MOU constitutes an understanding between the parties but is a non-binding agreement. it is FDA's policy to enter into MOUs with other entities whenever there is a need to define lines of authority or responsibility, or to clarify cooperative procedures. FDA Memorandum of Understanding C142486 C67497 CDISC Glossary message (HL7) The atomic unit of data transferred between systems. It comprises a group of segments in a defined sequence, each message has a message type that defines its purpose. NOTE: For example, the Admission, Discharge and Transfer (ADT) Message type is used to transmit portions of a patient's ADT data from one system to another. in HL7, a three-character code contained within each message identifies its type. [HL7] Data Message C184389 C67497 CDISC Glossary meta-analysis protocol The document describing the plan for combining of evidence from relevant studies using appropriate statistical methods to allow inference to be made to the population of interest. NOTE: The most common reason for performing a meta-analysis is to provide an estimate of a treatment effect or measure of relative risk associated with an intervention and to quantify the uncertainty about the estimated effect or risk, when data from a single existing study are insufficient for this purpose. [FDA Draft Guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry, November 2018] See also meta-analysis. Meta-Analysis Protocol Document C17886 C67497 CDISC Glossary meta-analysis The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. NOTE: This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. The methodology for performing the meta-analysis can be found in a meta-analysis protocol, or plan. [After ICH E9 Glossary] See also meta-analysis protocol. Meta-Analysis C19536 C67497 CDISC Glossary metabolism The biochemical alteration of substances introduced into the body. Metabolic Process C52095 C67497 CDISC Glossary metadata Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields. Metadata C142726 C67497 CDISC Glossary migration The act of moving a system or software product (including data) from an old to new operational environment in accordance with a software quality system. ISO/IEC/IEEE 12207:1995 5.5.5] System Migration C156663 C67497 CDISC Glossary minor A subject who, according to the law of the applicable jurisdiction concerned, is under the age of legal competence to give informed consent. [after EU CTR] Minor Person C142610 C67497 CDISC Glossary missing data Data not completed or corrupted in reports and case report forms, e.g., the data not captured when a subject withdraws from a trial. NOTE: Reviewers are concerned about missing data since patients who are not improved or who believe they have experienced side effects may be particularly prone to leave a trial, thus skewing the analysis of results if such analysis were to be done only on the subjects who had continued with the trial. Trial designs therefore specify plans for how such missing data will be treated in analysis. See also intention to treat. [FDA Guidance on Subject Withdrawal, 2008] Missing Data C53320 C67497 CDISC Glossary mode The most frequently occurring value in a data set. Mode C16866 C67497 CDISC Glossary model A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context (e.g., clinical trial data). [CDISC] Model C50072 C67497 CDISC Glossary modem From modulator/ demodulator; a device that converts digital data into analog data that can be transmitted via telephone or cable lines used for communications. Modem Device C103246 C67497 CDISC Glossary moiety An entity that has a complete and continuous molecular structure and is part of a substance. The active moiety of the molecule is the basis for the physiological or pharmacological action of the drug substance. NOTE: The strength of a pharmaceutical product is often based on what is referred to as the active moiety. [after ISO 11238 2012-11 on Regulated information on Substances] Chemical Moiety C41201 C67497 CDISC Glossary monitor Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol and GCP guidance. NOTE: A monitor's duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial. [from ICH E6, 5.18] See also clinical research associate. Study Monitor C115753 C67497 CDISC Glossary monitoring plan A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. [ICH E6(R2) Glossary Addendum] See also monitoring. Clinical Trial Monitoring Plan C142708 C67497 CDISC Glossary monitoring report A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. [ICH] Study Monitoring Report C142709 C67497 CDISC Glossary monitoring visit A visit to a study site to review the progress of a clinical study and to ensure protocol adherence, accuracy of data, safety of subjects, and compliance with regulatory requirements and good clinical practice guidelines. [from ICH E6, 5.18] Study Monitoring Visit C61256 C67497 CDISC Glossary monitoring Act of overseeing, tracking, observing, evaluating or supervising over time by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring, data monitoring, risk based monitoring. Monitoring C184382 C67497 CDISC Glossary morbidity rate A measure of the frequency of occurrence of a specific disease, injury, or disability in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, incidence, prevalence, mortality rate, incidence rate. Morbidity Rate C16877 C67497 CDISC Glossary morbidity Departure from physiological or psychological health, i.e., disease, injury, or disability. NOTE: Most often measures of morbidity frequency characterize the number of persons in a population who become ill (incidence) or are ill at a given time (prevalence). See also morbidity rate, incidence, prevalence, mortality rate, incidence rate, virulence. Morbidity C16880 C67497 CDISC Glossary mortality rate A measure of the frequency of occurrence of death in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, morbidity rate, incidence, prevalence, incidence rate. Mortality Rate C16104 C67497 CDISC Glossary multicenter trial Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/institution, study. Multi-Institutional Clinical Trial C156635 C67497 CDISC Glossary mutual recognition procedure (MRP) The EU procedure to be used when a product is already authorized in at least one Member State and the Marketing Authorization Holder wishes to obtain a Marketing Authorization (MA) for the same product in at least one other Member State. The Member State that has already authorized the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member State/s (CMS). If the applicant is successful, the CMS will then issue a MA for that product permitting the marketing of that product in their country. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Reference Member State (RMS) and Concerned Member State (CMS). Mutual Recognition Procedure C142614 C67497 CDISC Glossary n-of-1 study A trial in which an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment's effect in that person, often with the order of experimental and control treatments randomized. N-of-1 Study C176260 C67497 CDISC Glossary natural language processing The use of algorithms to determine properties of natural, human language so that computers can understand what humans have written or said. NLP includes teaching computer systems how to extract data from bodies of written text, translate from one language to another, and recognize printed or handwritten words. NOTE: NLP is the field that allows for our everyday use of virtual assistants such as Siri, Alexa, or Google. [After DeepAI Definitions] See also artificial intelligence (AI). Natural Language Processing C142612 C67497 CDISC Glossary natural language Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines. Natural Language C43515 C67497 CDISC Glossary NCI Enterprise Vocabulary Services (EVS) A US national resource to house and maintain a number of health-related glossaries and controlled vocabularies under strict versioning. Provides resources and services to meet the National Cancer Institute's needs for controlled terminology, and to facilitate the standardization of terminology and information systems across the NCI and the larger biomedical community. NCI Enterprise Vocabulary Services C72899 C67497 CDISC Glossary New Drug Application (NDA) An application to FDA for a license to market a new drug in the United States. New Drug Application C142613 C67497 CDISC Glossary new safety information Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)] New Safety Information C156651 C67497 CDISC Glossary NOEL (no observable effect level) The dose of an experimental drug given preclinically that does not produce an observable toxicity. No Observable Effect Level C48298 C67497 CDISC Glossary nomenclature Application of naming conventions. Compare to vocabulary, terminology. Nomenclature C165828 C67497 CDISC Glossary non-confirmatory result In a trial, typically phase 3, results that fail to achieve statistical significance and therefore fail to confirm the preliminary evidence from other trials that a drug is safe and effective for use for the intended indication and population. NOTE: Non-confirmatory trial results provide useful scientific information. [After ICH E8] See also confirmatory trial. Non-confirmatory Result C184386 C67497 CDISC Glossary non-inferiority (NI) trial A type of controlled trial to demonstrate that the new treatment is not less effective than the active control by a specified amount. [After Non-Inferiority Clinical Trials to Establish Effectiveness. FDA Guidance for Industry. November 2016] Non-Inferiority Study C142615 C67497 CDISC Glossary non-interventional study A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. [Clinical Trial Directive EC/20/2001 definitions] Non-Interventional Study C48678 C67497 CDISC Glossary nonclinical study Biomedical studies not performed on human subjects. [ICH E6 (R2)] Nonclinical Study C142554 C67497 CDISC Glossary not approvable letter An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected. FDA Not Approvable Letter C142545 C67497 CDISC Glossary Notified Body (NB) A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB. European Union Notified Body C142616 C67497 CDISC Glossary null hypothesis The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. NOTE: A null hypothesis (for example, "subjects will experience no change in blood pressure as a result of administration of the test product") is used to rule out every possibility except the one the researcher is trying to prove, and is used because most statistical methods are less able to prove something true than to provide strong evidence that it is false. The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. See also research hypothesis. [from AMA Manual of Style] Null Hypothesis C142617 C67497 CDISC Glossary Nuremberg Code A code of ethics set forth in 1947 for the conduct of medical research, with the express purpose of protecting human medical research subjects. Nuremberg Code C142450 C67497 CDISC Glossary objective The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. [After ICH E8] See also primary objective, secondary objective. Clinical Trial Objective C116555 C67497 CDISC Glossary observation An assessment of patient condition in data collected on an individual patient or group of patients. Note: In SDTM, an observation refers to a discrete piece of information collected during a study, e.g., measures used to assess an outcome. [SDTM] See also variable, outcome. Clinical Observation C16084 C67497 CDISC Glossary observational study A non-interventional study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate, within a study population, and where the independent variable is not under the control of the researcher. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York; www.strobe-statement.org] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial. Observational Study C142619 C67497 CDISC Glossary observer assessment An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.). NOTE: Distinguished from self-assessment. The observer relies on his or her judgment to assess the subject. an interviewer simply capturing subject self assessments is not making an observer assessment. Compare to PRO, proxy assessment. Observer Assessment C142620 C67497 CDISC Glossary observer-reported outcome (ObsRO) A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviors related to a patient's health condition by someone other than the patient or a health professional. [After BEST Resource] Observer-reported Outcome C132346 C67497 CDISC Glossary official protocol title scientific protocol title The formal descriptive name for the protocol sufficient to describe key elements of the study, aimed at a scientific audience. NOTE: The official protocol title should include the study acronym, if applicable [After WHO ICTRP]. The official protocol title should be sufficiently different from other official protocol titles to create brevity with specificity [NIH Protocol Template]. In the case of a master protocol, the study title may be more specific than the protocol title. See also protocol title, public protocol title. Official Protocol Title C21270 C67497 CDISC Glossary ontology An explicit formal specification of how to represent relationships among objects, concepts, and other entities that belong to a particular domain of experience or knowledge. See also terminology. Ontology C142621 C67497 CDISC Glossary open to enrollment The status of a study such that a subject can be enrolled into that study. NOTE: Registry terminology in common use is "open to recruitment"; however, recruitment can begin upon IRB approval of the site; whereas enrollment requires availability of study supplies, subject informed consent, etc., to allow participation of eligible subjects. Open To Enrollment C49659 C67497 CDISC Glossary open-label study A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding. Open Label Study C142622 C67497 CDISC Glossary operational model The set of CDISC data standards (including ODM and LAB) used to capture and archive data from clinical trials. Operational Model C142580 C67497 CDISC Glossary opinion (in relation to independent ethics committee) The judgment and/or the advice provided by an independent ethics committee. [ICH E6 Glossary] Independent Ethics Committee Opinion C142623 C67497 CDISC Glossary original data The first recorded study data values. NOTE: FDA is allowing original documents and the original data recorded on those documents to be replaced by copies provided that the copies have been verified as identical in content and meaning. (see FDA Compliance Policy Guide 7150.13). [Modified from CSUICI] See also certified copy, source. Original Data C82521 C67497 CDISC Glossary other serious (important medical events) A category of important medical events that may not be immediately life-threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event. Note: These "Other serious" events require medical and scientific judgement in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event. Other Medically Important Serious Event C49489 C67497 CDISC Glossary outcome (of adverse event) Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved, recovering/ resolving, not recovered/not resolved, recovered/resolved with sequelae, fatal, or unknown. [SDTM events class of observation] Adverse Event Outcome C93407 C67497 CDISC Glossary outcome measure Specific key measurement(s) or observation(s) used to determine the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. (After BRIDG) Study Outcome Measurement C20200 C67497 CDISC Glossary outcome The measureable characteristic (clinical outcome assessment, biomarker) that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation. Outcome C15365 C67497 CDISC Glossary outcomes research Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions. NOTE: Usually distinguished from research conducted solely to determine efficacy and safety. [Guyatt et al., 1993] See also pharmacoeconomics, quality of life. Outcomes Research C79083 C67497 CDISC Glossary outliers Values outside of an expected range. Outlier C50873 C67497 CDISC Glossary overdose Administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information. [After, EU Guideline on good pharmacovigilance practices (GVP)] Overdose C44185 C67497 CDISC Glossary p-value The probability that the observed data could have arisen by chance when the interventions did not differ. [After AMA Manual of Style] See also null hypothesis. P-Value C185295 C67497 CDISC Glossary packaging The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials Packaging Materials C142624 C67497 CDISC Glossary pairing matching A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B. See also matched-pair design. Pairing C171519 C67497 CDISC Glossary pandemic An epidemic occurring worldwide, or over a very wide area, crossing international boundaries, and usually affecting a large number of people. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001] Pandemic Disorder C82639 C67497 CDISC Glossary parallel trial parallel design trial; parallel group trial A trial design in which subjects are assigned to one of two or more different treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. [After ICH E9; EMA NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS, September 1998] Parallel Study C44175 C67497 CDISC Glossary parameter A variable in a model, or a variable that wholly or partially characterizes a probability distribution (mathematics and statistics). NOTE: in clinical trials the term is often used synonymously with 'variable' for factual information (age, date of recovery), measurements, and clinical assessments. it is most appropriately linked to statistical conventions and as a numeric characteristic of a population. Parameters are rarely known and are usually estimated by statistical computation from samples. Thus the term is narrower than variable. [Parexel Barnett; ADaM; HyperStat Online] See also variable, outcome. Parameter C156779 C67497 CDISC Glossary participant A person or entity with a role in a clinical study. NOTE: Participants can be human subjects or study personnel. The term "participant" is used with growing frequency in some clinical and patient-facing documents like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, study participant. Entity With Role in Clinical Study C142626 C67497 CDISC Glossary password aging A practice applying to multi-user computer systems where the validity of a password expires after a certain pre-set period. NOTE: FDA requires that passwords that are part of electronic signatures be "periodically checked, recalled or revised," but does not mandate password aging. [After NIST, 21 CFR 11] Password Aging C142627 C67497 CDISC Glossary patient file One that contains demographic, medical, and treatment information about a patient or subject. It may be paper- or computer-based or a mixture of computer and paper records. Patient File C16960 C67497 CDISC Glossary patient Person under a physician's care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. Although often used interchangeably as a synonym for subject, a healthy volunteer is not a patient. See also human subject, clinical research subject, healthy volunteer, participant. Patient C95401 C67497 CDISC Glossary patient-reported outcome (PRO) A type of clinical outcome assessment. A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else. NOTE: A PRO can be measured by self-report or by interview provided that the interviewer records only the patient's response. Symptoms or other unobservable concepts known only to the patient can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others. [After BEST Resource] Patient Reported Outcome C142635 C67497 CDISC Glossary per-protocol analysis set The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model. [ICH E9] Per-Protocol Analysis Set C142632 C67497 CDISC Glossary performance outcome (PerfO) A PerfO is a measurement based on a task(s) performed by a patient according to instructions that is administered by a health care professional. NOTE: Performance outcomes require patient cooperation and motivation. These include measures of gait speed (e.g., timed 25 foot walk test), memory recall, or other cognitive testing (e.g., digit symbol substitution test). [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. After BEST Resource] Performance Outcome C70900 C67497 CDISC Glossary performed activity Clinical trial events as they actually occurred (as compared with events planned in the protocol). Performed Clinical Study Activity C142633 C67497 CDISC Glossary period effect An effect occurring during a period of a trial in which subjects are observed and no treatment is administered. Period Effect C142634 C67497 CDISC Glossary permanent data Data that become or are intended to become part of an electronic record in relation to a regulatory submission. NOTE: Any changes made to such permanent data are recorded via an audit trail so that prior values are not obscured. Permanent Data C41109 C67497 CDISC Glossary permissible values Limited universe of options for data items. (e.g., drop-down menus, codelists, pick lists). Permissible Value C90492 C67497 CDISC Glossary personally identifiable information (PII) Any information about an individual maintained by an agency (or group) including but not limited to, education, financial transactions, medical history, and criminal or employment history, which can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, biometric records, etc., including any other personal information that is linked or linkable to an individual. Used in US [NIST Special publication 800-122] Personal Information C42639 C67497 CDISC Glossary pharmaceutical product Qualitative and quantitative composition of a medicinal product in the dose form authorized by the regulatory authority for administration to patients, and as represented with any corresponding regulated product information. NOTE: A medicinal product may contain one or more pharmaceutical products. In many instances, the pharmaceutical product is the manufactured item. However, there are instances where the manufactured item undergoes further preparation before being administered to the patient (as the pharmaceutical product). [After ISO 11615:2017, 3.1.60] Finished Pharmaceutical Product C15720 C67497 CDISC Glossary pharmacodynamics Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents. Pharmacodynamics C142636 C67497 CDISC Glossary pharmacoeconomics Branch of economics that applies cost-benefit, cost-utility, cost-minimization, and cost-effectiveness analyses to assess the utility of different pharmaceutical products or to compare drug therapy to other treatments. Pharmacoeconomics C68761 C67497 CDISC Glossary pharmacogenetic test An assay intended to study interindividual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test. Pharmacogenetic Test C16973 C67497 CDISC Glossary pharmacogenetics Study of the way drugs interact with genetic makeup or the study of genetic response to a drug. Pharmacogenetics C68762 C67497 CDISC Glossary pharmacogenomic test An assay intended to study interindividual variations in whole genome or candidate gene maps, biomarkers, and alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response. Compare to pharmacogenetic test. Pharmacogenomic Test C20050 C67497 CDISC Glossary pharmacogenomics Science that examines inherited variations in genes that dictate drug response and explores the ways such variations can be used to predict whether a person will respond favorably, adversely, or not at all to an investigational product. Pharmacogenomics C15299 C67497 CDISC Glossary pharmacokinetics Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products. Pharmacokinetics C16974 C67497 CDISC Glossary pharmacology Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms. Pharmacology C142637 C67497 CDISC Glossary pharmacovigilance Process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect 'signals' (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP] See also postmarketing surveillance. Pharmacovigilance C176261 C67497 CDISC Glossary phase (within a study) A stage in the sequence of activities in a clinical study (e.g., Screening, Randomization, Treatment, Follow-up). See also arm, visit, phase (of clinical development), epoch. Study Phase C54721 C67497 CDISC Glossary phase 0 Originally described as an exploratory study with no safety or efficacy targets. It is not cited in current FDA guidance and no longer in common usage. See also phase. Phase 0 Trial C15600 C67497 CDISC Glossary phase 1 The initial introduction of an investigational new drug into humans. Phase 1 studies are closely monitored and are most often conducted in normal healthy volunteer subjects but in specific cases also in patients. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after ICH E8; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also phase. Phase I Trial C15601 C67497 CDISC Glossary phase 2 Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b. Phase II Trial C49686 C67497 CDISC Glossary phase 2a Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] See also phase, phase 2, phase 2b. Phase IIa Trial C49688 C67497 CDISC Glossary phase 2b Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.] See also phase, phase 2, phase 2a. Phase IIb Trial C15602 C67497 CDISC Glossary phase 3 Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b. Phase III Trial C49689 C67497 CDISC Glossary phase 3b Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. See also phase, phase 3. Phase IIIb Trial C15603 C67497 CDISC Glossary phase 4 Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase. Phase IV Trial C47865 C67497 CDISC Glossary phase 5 Postmarketing surveillance to monitor product safety and efficacy. See also outcomes research, phase, postmarketing surveillance. Phase V Trial C48281 C67497 CDISC Glossary phase phase (of clinical development) A stage in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development. Trial Phase C753 C67497 CDISC Glossary placebo A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product. Placebo C176262 C67497 CDISC Glossary plain language writing Writing in a way that helps readers understand the content in a document the first time they read it. Note: Plain writing is intended to be clear, concise, well-organized, and follow other best practices appropriate to the topic or field and the intended audience. [After Plain Writing Act of 2010, FDA]. See also health literacy. Plain Language Writing C202581 C67497 CDISC Glossary platform trial design A type of trial design under a master protocol framework that tests multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design. Platform Trial Design C17005 C67497 CDISC Glossary population Any finite or infinite collection of subjects from which a sample is drawn for a study to obtain estimates for values that would be obtained if the entire population were sampled. [AMA style Manual] Population Group C142639 C67497 CDISC Glossary postmarketing commitment (PMC) Studies that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [FDA Webpage Postmarketing Requirements and Commitments: Introduction, 01/12/2016] See also postmarketing requirement. Compare to postmarketing requirement (PMR). Postmarketing Commitment C97025 C67497 CDISC Glossary postmarketing requirement (PMR) FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment (PMC). Post Marketing Requirement C142640 C67497 CDISC Glossary postmarketing surveillance Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies, pharmacovigilance. Postmarketing Surveillance C142641 C67497 CDISC Glossary pragmatic trial A trial that compares health interventions in a diverse population representing clinical practice. These trials inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. NOTE: These trials may or may not be randomized and can be large simple studies. [After GetReal - Project No. 115546l, WP1: Deliverable D1.3, Glossary of Definitions of Common Terms; Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454-63.] See also Real-World Data (RWD), Real-World Evidence (RWE), confirmatory trial. Pragmatic Trial C71724 C67497 CDISC Glossary pre-approval access A potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. NOTE: The intent is treatment, as opposed to research. Individual, Intermediate-size, and Widespread Use Expanded Access, also Emergency IND, are all programs administered under FDA guidelines. Additionally, the US Right-to-Try Act, which is independent of FDA, expands access. [FDA Expanded Access: Information for Physicians] Compassionate Treatment C70880 C67497 CDISC Glossary pre-market approval application (PMA) An application to FDA for a license to market a new device in the United States. Pre-market Approval Application C142555 C67497 CDISC Glossary preamble A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: "The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue" raised in comments submitted in response to the proposed regulation. [After 21CFR10.40] FDA Regulation Preamble C142642 C67497 CDISC Glossary preclinical studies Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP). NOTE: Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials). Preclinical Study C17010 C67497 CDISC Glossary prevalence The number of the existing cases of disease or injury in a defined population at a given point in time. NOTE: The relation between incidence and prevalence varies among diseases. There may be low incidence and a high prevalence - as for diabetes - or a high incidence and a low prevalence - as for the common cold. [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to incidence. See also morbidity rate, morbidity, mortality, incidence rate. Prevalence C142643 C67497 CDISC Glossary primary completion date The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome [measure], whether the clinical trial concluded according to the pre-specified protocol or was terminated. NOTE: The primary completion date may or may not be the same as the study completion date. [ClinicalTrials.gov] Primary Completion Date C85826 C67497 CDISC Glossary primary objective The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective, secondary objective. Trial Primary Objective C142644 C67497 CDISC Glossary primary outcome variable An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions. [CONSORT Statement] See also primary objective, outcome, endpoint. Primary Outcome Variable C19924 C67497 CDISC Glossary principal investigator An individual responsible and accountable for conducting clinical research studies in human subjects and leading a team if more than one investigator is involved with a clinical trial. NOTE: While the term is defined inconsistently within some guidance, in common usage, the term is used as defined above and the accountabilities are assigned by the sponsor. [After ICH E6 and WHO]. Principal Investigator C156637 C67497 CDISC Glossary privacy breach A privacy breach is the loss of, unauthorized access to, or disclosure of, personal information. [Office of the Privacy Commissioner of Canada] See also serious breach. Privacy Breach C95344 C67497 CDISC Glossary product dose The amount of a product administered in a single dose at a point in time. Usually expressed as a weight, volume, or a number of items (e.g., dosage forms) administered. The expression refers to the substance(s) contained in the Product. Product Dose C102988 C67497 CDISC Glossary PROMIS NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function, and emotional well-being. [NIH] Patient Reported Outcomes Measurement Information System C15843 C67497 CDISC Glossary prophylaxis prevention Practices or interventions used to help people stay healthy and avoid disease. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015] Preventive Intervention C71898 C67497 CDISC Glossary proprietary name Brand Name; Trade Name A commercial name for a drug product, granted by a naming authority for use in marketing a drug/device product. [After SPL; After FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name. Proprietary Name C142646 C67497 CDISC Glossary prospective study A study with planned observations collected predominantly after the start of the study (i.e. forward-looking). Note: Examples are interventional clinical trials, including clinical trials with an adaptive trial design. [After ClinicalTrials.gov] See also retrospective study, interventional clinical trial, observational study, adaptive design, clinical study. Prospective Study C142647 C67497 CDISC Glossary protected personal data (PPD) Any information relating to an identified or identifiable natural person (data subject); an identifiable person is one who can be identified directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his/her physical, psychological, mental, economic, cultural or social identity. Used in Europe [EU Directive 95/46/EC] Protected Personal Data C132347 C67497 CDISC Glossary protocol amendment(s) A written description of a change(s) to or formal clarification of a protocol. NOTE: If a protocol modification is substantial, it may require notification to the regulatory authority. For example, substantial impacts on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial. [ICH E3; ICH E6 (R2) Glossary 1.45] Protocol Amendment C142648 C67497 CDISC Glossary protocol approval (Sponsor) Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated. NOTE: Approval by the sponsor usually initiates secondary approvals by IRBs, regulatory authorities, and sites. Protocol amendments usually also require a cycle of approval by sponsor and study staff prior to taking effect. Protocol Approval by Sponsor C50996 C67497 CDISC Glossary protocol deviation A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE: Good clinical practice recommends that deviations be summarized by site and by category as part of the report of study results so that the possible importance of the deviations to the findings of the study can be assessed. Compare to protocol violation. [See ICH E3] Protocol Deviation C132299 C67497 CDISC Glossary Protocol Identifying Number Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [EudraCT] Protocol Identifier C142650 C67497 CDISC Glossary protocol referenced documents Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol. Protocol Referenced Documents C132300 C67497 CDISC Glossary protocol title The name of a study protocol. NOTE: In most cases the protocol title is the same as the study title but in certain cases the titles may be different. See also official protocol title, public protocol title, master protocol. Protocol Title C142185 C67497 CDISC Glossary protocol violation A significant departure from processes or procedures that were required by the protocol. Violations often result in data that are not deemed evaluable for a per-protocol analysis, and may require that the subject(s) who violate the protocol be discontinued from the study. Compare to protocol deviation. Protocol Violation C142451 C67497 CDISC Glossary protocol clinical protocol; study protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. [ICH E6 Glossary] Clinical Trial Protocol C142651 C67497 CDISC Glossary proxy (as an origin of outcome measures) A proposed standardized qualifier variable to describe the origin of observations of the Findings class resulting from outcomes measures. Proxy describes outcome data furnished by someone other than the patient and distinguishes the origin of the outcome from a self-report (PRO) directly from the patient. NOTE: The term proxy helps qualify outcomes measures that record feelings and symptoms reported by the patient but not recorded directly. [CDISC (extension of SDTM based on Table 2 Patrick, D.L., 2003)] See also observer assessment. Proxy Data Origin C142652 C67497 CDISC Glossary proxy respondent Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. [Patrick, D.L., 2003; DIA ePRO Workgroup] Compare to observer assessment. Proxy Respondent C142653 C67497 CDISC Glossary proxy-reported outcome A measurement based on a report by someone other than the patient reporting as if he or she is the patient. NOTE: A proxy-reported outcome is not a patient-reported outcome (PRO). FDA does not consider a proxy-reported outcome as a valid endpoint. [After FDA Clinical Outcome Assessment (COA) Glossary] Proxy-reported Outcome C142654 C67497 CDISC Glossary pseudonymization A privacy preservation technique that both replaces the direct association with a data subject and adds an association between a particular set of characteristics relating to the data subject and one or more pseudonyms. Typically, psuedonymization is implemented by replacing direct identifiers (like the subject's name) with a pseudonym such as a randomly generated value. [ISO/TS 25237:2008] Pseudonymization C142655 C67497 CDISC Glossary psychometric reliability reliability, psychometric The degree to which a psychometric 'instrument' is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time. NOTE: Reliability pertains to questions concerning whether an instrument is accurate, repeatable, and sensitive. Reliability is distinguished from validation, which answers whether the instrument (e.g., questionnaire) actually measure the selected "construct" (latent variable). For example a balance (scale) is easily understood as a possibly valid instrument to measure body weight. Its reliability would be assessed by measuring the sensitivity, repeatability, and accuracy of the balance. The validity of using the balance for a particular purpose could then be established by comparing the measured reliability to the reliability required for that purpose. [After Patrick, D.L., 2003] Compare to psychometric validation. See also validation, instrument. Psychometric Instrument Reliability C142656 C67497 CDISC Glossary psychometric validation validity, psychometric The specialized process of validating questionnaires used in outcomes research to show that they measure what they purport to measure. NOTE: Several types of validity are distinguished. For example, [Guyatt et al., 1993; DIA ePRO Workgroup] See also validation; compare to psychometric reliability. Psychometric Validation C17034 C67497 CDISC Glossary psychometrics The science of assessing the measurement characteristics of scales that assess human psychological characteristics. Psychometrics C94105 C67497 CDISC Glossary public protocol title brief protocol title; short protocol title A brief description intended for the lay public in easily understood language. NOTE: Public title may also be referred to as "brief title." [Segen's Medical Dictionary] See also protocol title, official protocol title. Study Protocol Document Version Public Title C142657 C67497 CDISC Glossary qualitative variable One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes. Qualitative Variable C15381 C67497 CDISC Glossary quality assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH E6 R2 Glossary] Quality Assurance C15311 C67497 CDISC Glossary quality control (QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled. [ICH E6 R2 Glossary] Quality Control C17047 C67497 CDISC Glossary quality of life (QoL) A broad ranging concept that incorporates an individual's physical health, psychological state, level of independence, social relationships, personal beliefs, and their relationships to salient features of the environment. NOTE: Quality of life is one way to measure the benefits or negative impacts of an "improvement" measured in terms of a physiological or psychological symptom. QoL research seeks to quantify what an intervention means to a patient's sense that their life has changed. NOTE: See also definition from FDA eCOA Glossary. [WHO Group, 1994] Quality of Life C142658 C67497 CDISC Glossary quantitative variable One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum. Quantitative Variable C142481 C67497 CDISC Glossary query management Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data. Data Item Query Management C142482 C67497 CDISC Glossary query resolution The closure of a query usually based on information contained in a data clarification. Data Item Query Resolution C142480 C67497 CDISC Glossary query A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor's representative to an investigator to resolve an error or inconsistency discovered during data review. Data Item Query C17048 C67497 CDISC Glossary questionnaire A set of questions or items shown to a respondent in order to get answers for research purposes. [PRO Draft Guidance] See also instrument, survey. Questionnaire C17049 C67497 CDISC Glossary race An arbitrary classification of a taxonomic group that is a division of a species. It usually arises as a consequence of geographical isolation within a species and is characterized by shared heredity, physical attributes and behavior, and in the case of humans, by common history, nationality, or geographic distribution. (NCI) Race C142659 C67497 CDISC Glossary radiopharmaceutical medicinal product Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose. [DIRECTIVE 2001/83/EC Article 1.(11)] Radiopharmaceutical Medicinal Product C142660 C67497 CDISC Glossary random allocation Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: in a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience. Random Allocation C142661 C67497 CDISC Glossary random number table Table of numbers with no apparent pattern used in the selection of random samples for clinical trials. Random Number Table C142662 C67497 CDISC Glossary random sample Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection. Random Sample Population C25196 C67497 CDISC Glossary randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Randomization can be executed according to imposed rules to achieve desired distribution. For example, unequal randomization is used to allocate subjects into groups at a differential rate, e.g., three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. Randomization C46079 C67497 CDISC Glossary randomized controlled trial (RCT) Randomized Controlled Clinical Trial A well-controlled clinical trial in which subjects are assigned to treatment or control groups according to randomization principles. See randomization. [After FDA and Clinical Drug Trials : A Short History, S.White Junod, 2008; CONSORT statement] See also randomization, clinical trial, controlled study, adequate and well-controlled studies. Randomized Controlled Clinical Trial C142663 C67497 CDISC Glossary raw data Data as originally collected. Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes, evaluations, data recorded by automated instruments) without conclusions or interpretations. Researcher's records of subjects/patients, such as patient medical charts, hospital records, X-rays, and attending physician's notes. NOTE: These records may or may not accompany an application to a Regulatory authority, but must be kept in the researcher's file. See also eSource, source data, source documents. Raw Data C142666 C67497 CDISC Glossary RCRIM Regulated Clinical Research and information Management, which is a Technical Committee within HL7 (an acronym pronounced "arcrim"). Regulated Clinical Research and Information Management C165830 C67497 CDISC Glossary Real-World Data (RWD) Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Evidence (RWE) Real-world Data C165831 C67497 CDISC Glossary Real-World Evidence (RWE) The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. [After FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No. 115546, WP1: Deliverable D1.3; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Data (RWD). Real-world Evidence C142712 C67497 CDISC Glossary reconstruction (of a study) For eClinical trials FDA expects archival trial records to support review of the data as well as the processes used for obtaining and managing the data so that the trustworthiness of results obtained can be evaluated. NOTE: Reconstruction from records should support evaluation of the operation and validity of computerized systems and the conformance of the systems to applicable regulations during design and execution of the trial as well as during the period of record retention. [from CSUCT VI D, 21 CFR Parts 11, 312] Study Reconstruction C25198 C67497 CDISC Glossary record In a regulated environment, documented information in any format that is subject to the requirements for data integrity, and should be controlled and maintained. NOTE: The requirements for data integrity are covered by the ALCOA plus principles. [After 21 CFR Part 11, Parts 210, 211, and 212; 21 CFR 312.61 and 312.62] See also data integrity, ALCOA plus, electronic record, control of electronic records, EHR (electronic health record), electronic personal health record (ePHR), EMR (electronic medical record), trustworthy (electronic records), source data, source document. Record C142590 C67497 CDISC Glossary recruitment (investigators) Process used by sponsors to identify, select, and arrange for investigators to serve in a clinical study. Investigator Recruitment Process C78343 C67497 CDISC Glossary recruitment (subjects) Process used by investigators to find and enroll appropriate subjects (those selected on the basis of the protocol's inclusion and exclusion criteria) into a clinical study. Recruitment C142664 C67497 CDISC Glossary recruitment period Time period during which subjects are or are planned to be enrolled in a clinical trial Recruitment Period C142665 C67497 CDISC Glossary recruitment target Number of subjects that must be recruited as candidates for enrollment into a study to meet the requirements of the protocol. in multicenter studies, each investigator has a recruitment target. Recruitment Target C80496 C67497 CDISC Glossary Reference information Model (RIM) An information model used as the ultimate defining reference for all HL7 standards. [HL7] Reference Information Model C156641 C67497 CDISC Glossary reference member state (RMS) A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. The first Member State that has authorized the product in the RMS. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem .html] See also Mutual Recognition Procedure (MRP) and Concerned Member State (CMS). Reference Member State C165832 C67497 CDISC Glossary regenerative medicine advanced therapy (RMAT) designation An FDA designation for regenerative medicine therapies to treat, modify, reverse, or cure serious conditions that are eligible for FDA's expedited programs if they meet the criteria for such programs. [After http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine therapy (RMT), regenerative medicine. Regenerative Medicine Advanced Therapy Designation C165833 C67497 CDISC Glossary regenerative medicine therapy (RMT) A treatment to repair or replace damaged cells, tissues, or organs, including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. NOTE: RMT may include human gene therapies, genetically modified cells that lead to a sustained effect on cells or tissues, xenogeneic cell products, and any combination product where the biological product constituent part is a regenerative medicine therapy (biologic-device, biologic-drug, or biologic device-drug). [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy. Regenerative Medical Therapy C93254 C67497 CDISC Glossary regenerative medicine A broad field of medicine that endeavors to create living functional human cells, tissues, and organs to repair or replace tissues or organ function lost due to age, disease, damage, or congenital defects. [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy. Regenerative Medicine C93453 C67497 CDISC Glossary registry A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions. NOTE: The registry should contain basic information about each trial sufficient to inform interested subjects (and their healthcare practitioners) how to enroll in the trial. [FDAMA 113] Study Registry C70868 C67497 CDISC Glossary regulatory application Application made to a health authority to investigate, market, or license a new product or indication. Regulatory Application C88081 C67497 CDISC Glossary regulatory authorities health authority Bodies having the power to regulate. NOTE: In the ICH GCP guideline the term includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities. [ICH] Regulatory Authority C165834 C67497 CDISC Glossary remote clinical trial A trial designed to reduce or eliminate travel by subjects to an investigative site for treatment and completion of study related procedures by implementing virtual visits (e.g., via electronic communication). [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also virtual, decentralized clinical trial. Remote Clinical Trial C142667 C67497 CDISC Glossary repeat rule Guide for repeating activities specified in protocol, including such features as the number of cycles and the criteria for stopping. Repeat Activity Until Rule C142738 C67497 CDISC Glossary replacement The act of enrolling a new study subject to compensate for a subject who is no longer participating. Trial Subject Replacement C25375 C67497 CDISC Glossary report A document that presents information in a structured format intended for a specific purpose and recipient. See also final report, interim clinical trial/study report, monitoring report, document (HL7), clinical study (trial) report. Report C165835 C67497 CDISC Glossary rescue medications Medicinal products identified in the protocol as those that may be administered to subjects when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. [After EU-CTR Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017] Rescue Medications C142668 C67497 CDISC Glossary research hypothesis The proposition that a study sets out to support (or disprove); for example, "blood pressure will be lowered by [specific endpoint] in subjects who receive the test product." See also null hypothesis. Research Hypothesis C142669 C67497 CDISC Glossary residual risk In assessing the risk of re-identifying a trial participant, the risk that remains after controls are taken into account (the net risk or after controls). [Institute of Medicine report, Appendix B] Residual Risk C142670 C67497 CDISC Glossary response option One of several choices to be available for selection in response to a prompt, question or instruction (i.e., a stem) in a PRO item. See also common data element, stem. Response Option C115629 C67497 CDISC Glossary result synopsis The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information. Clinical Study Report Synopsis C142671 C67497 CDISC Glossary results posting (results submission) The process of submitting and updating summary information about the results of a clinical study to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov] Results Posting C142672 C67497 CDISC Glossary results posting date (results submission date) The date and time the summary information about the results of the clinical study are submitted to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov] Results Posting Date C142673 C67497 CDISC Glossary retrospective data capture Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in real-time. NOTE: Retrospective capture is important in PROs because of "recall bias" and other errors documented in psychological research comparing contemporaneous self-reported assessments and those that rely on recall from memory. Retrospective Data Capture C53312 C67497 CDISC Glossary retrospective study A study with planned observations collected predominantly before study start (i.e. backward-looking). Note: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [after ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study. Retrospective Study C156652 C67497 CDISC Glossary RHIO (Regional Health Information Organization) A group of organizations with a business stake in improving the quality, safety and efficiency of healthcare delivery. RHIOs are the building blocks of the proposed National Health Information Network (NHIN) initiative. Regional Health Information Organization C142674 C67497 CDISC Glossary risk based monitoring A systematic, prioritized, risk-based approach to monitoring clinical trials. [After ICH E6(R2), 5.18.3] Risk Based Monitoring C142718 C67497 CDISC Glossary risk In clinical trials, the probability of harm or discomfort for subjects. NOTE: Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of troubling side effects. However, the possibility of unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness. Subject Risk C142414 C67497 CDISC Glossary role (CDISC classifier) Classifier for variables that describe "observations" in the SDTM. Role is a metadata attribute that determines the type of information conveyed by an observation-describing variable and standardizes rules for using the describing variable. [SDTM] CDISC Classifier Role C38114 C67497 CDISC Glossary route of administration (ROA) Path by which the pharmaceutical product is taken into or makes contact with the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form. Route of Administration C142675 C67497 CDISC Glossary SAFE BioPharma(TM) Digital Identity and Signature Standard. SAFE-Biopharma Standard C142676 C67497 CDISC Glossary safety and tolerability The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs, and symptoms), and other special safety tests (e.g., ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9] Safety and Tolerability C60828 C67497 CDISC Glossary safety Relative freedom from harm. In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects. Safety C142677 C67497 CDISC Glossary sample size adjustment An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9] Sample Size Adjustment C115467 C67497 CDISC Glossary sample size calculation A statistical calculation to determine the number of subjects required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. [After ICH E9, 3.5] Sample Size Calculation C53190 C67497 CDISC Glossary sample size A subset of a larger population, selected for investigation to draw statistically valid conclusions or make estimates about the larger population. NOTE: This number is presented in the protocol and statistical analysis plan. [After ICH E9] Sample Size C132349 C67497 CDISC Glossary schedule of activities Schedule of Events; SoA A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments. Compare to study design schematic. Schedule of Activities C142678 C67497 CDISC Glossary schedule of assessments A tabular representation of planned protocol events and activities, in sequence. [after E3 Annexes IIIa and IIIb] Compare to study design schematic. Schedule Of Assessments C49628 C67497 CDISC Glossary screen failure At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary] Trial Screen Failure C142721 C67497 CDISC Glossary screen/screening (of substances) Screening is the process by which substances are evaluated in a battery of tests or assays (screens) designed to detect a specific biological property or activity. It can be conducted on a random basis in which substances are tested without any preselection criteria or on a targeted basis in which information on a substance with known activity and structure is used as a basis for selecting other similar substances on which to run the battery of tests. [SQA] Substance Screening C142689 C67497 CDISC Glossary screening (of sites) Determining the suitability of an investigative site and personnel to participate in a clinical trial. Site Screening C48262 C67497 CDISC Glossary screening (of subjects) A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure. Trial Screening C202487 C67497 CDISC Glossary screening (period) A period in a clinical study during which subjects are evaluated for participation in the study. See also screening (of subjects) Screening Epoch C71485 C67497 CDISC Glossary screening trials A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov) Screening Study C96999 C67497 CDISC Glossary script A program or a sequence of instructions that are interpreted or carried out by another program or by a person. Script C85827 C67497 CDISC Glossary secondary objective Secondary objectives are supportive or ancillary questions of interest in a trial that will provide further information on the use of the treatment. See also primary objective, objective. Trial Secondary Objective C142680 C67497 CDISC Glossary secondary outcome variable Data on secondary outcomes are used to evaluate additional effects of the intervention. The primary outcome is the outcome of greatest importance. [after CONSORT statement] See also outcome, endpoint. Secondary Outcome Variable C142679 C67497 CDISC Glossary secondary sponsor Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. [WHO, CTR item 6] Secondary Sponsor C142681 C67497 CDISC Glossary self-evident change A data discrepancy that can be easily and obviously resolved on the basis of existing information on the CRF (e.g., obvious spelling errors or the patient is known to be a male and a date of last pregnancy is provided). See also discrepancy. Self-Evident Change C142682 C67497 CDISC Glossary semantic interoperability The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308] Semantic Interoperability C54194 C67497 CDISC Glossary semantic In the context of a technical specification, semantic refers to the meaning of an element as distinct from its syntax. syntax can change without affecting semantics. [HL7] Semantics C156653 C67497 CDISC Glossary SEND (standard for the exchange of nonclinical data) The CDISC standard for the exchange of nonclinical data whose focus is on data collected from animal toxicology studies. [CDISC] Standard for the Exchange of Nonclinical Data C142683 C67497 CDISC Glossary sensitive data Any data that, in the event of re-identification, would harm a patient in terms of employability, reputation, insurability, or self-esteem or results in loss of income. NOTE: Examples include history of alcoholism, drug abuse, risky behavior, or venereal disease. [HIPAA] Sensitive Data C142685 C67497 CDISC Glossary serious adverse drug reaction Adverse drug reaction that at any dose of the drug: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [1. WHO Technical Report 498(1972); 2. After ICH E2A, B] See ICH E6 definition and serious and severe definitions. Serious Adverse Drug Reaction C41335 C67497 CDISC Glossary serious adverse event (SAE) Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B] Compare to serious adverse drug reaction. Serious Adverse Event C142686 C67497 CDISC Glossary serious adverse experience (SAE) Any experience that suggests a significant hazard, contra-indication, side effect or precaution. See also serious adverse event. Serious Adverse Experience C156636 C67497 CDISC Glossary serious breach A breach of Clinical Trial Regulation (EU) No 536/2014 or of the version of the protocol applicable at the time of the breach, which is likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial. [Article 52 of Regulation (EU) 536/2014 and Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol] See also privacy breach. Serious Breach C142687 C67497 CDISC Glossary serious risk Risk of a serious adverse drug experience. [505-1(b) of FD&C Act (21 USC. 355-1(b)] Serious Risk C48297 C67497 CDISC Glossary server A computer that controls a central repository of data, files, and/ or applications that can be accessed and/or manipulated in some manner by client computers. NOTE: A file server hosts files for use by client machines. A web server supports browser-based use of central applications. Server C70667 C67497 CDISC Glossary severe An adjective for grading intensity on a relative scale describing a symptom, outcome or event. Note: The term 'severe' is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache). This is not the same as 'serious,' which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. [After ICH E2A, B] See also serious adverse event and serious adverse drug reaction. Severe C28421 C67497 CDISC Glossary sex Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender. Sex C2861 C67497 CDISC Glossary side effects Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction. Side Effect C53458 C67497 CDISC Glossary sign An observation by a medical professional obtained from examination, test result, or questionnaire that indicates a patient may have a disease. NOTE: Some examples of signs are fever, swelling, skin rash, high blood pressure, and high blood glucose. [After NCI Glossary] See also diagnosis, symptom. Sign C142688 C67497 CDISC Glossary signal of a serious risk Information related to a serious adverse drug experience associated with use of a drug and derived from-(a) a clinical trial; (b) adverse event reports; (c) a post-approval study; (d) peer-reviewed biomedical literature; (e) data derived from the post-market REMs. [505-1(b) of FD&C Act (21 USC. 355-1(b)] Signal of a Serious Risk C28233 C67497 CDISC Glossary single-blind study single-masked study A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called single-masked study. See also blind study, double-blind study, triple-blind study. Single Blind Study C165836 C67497 CDISC Glossary single-entity product A product composed of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity. [After 21 CFR 3.2 (e) FAQ] See also combination product, co-packaged product, cross-labeled product. Single-entity Product C51873 C67497 CDISC Glossary site investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [ICH E6 1.35. 2.] See also investigator, coordinating investigator, investigator/institution, principal investigator, sponsor-investigator, sub-investigator. Site Investigator C53489 C67497 CDISC Glossary SNOMED (Systematized Nomenclature of Medicine) A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. Terms are applied to one of eleven independent systematized modules. Systematized Nomenclature of Medicine C20188 C67497 CDISC Glossary social circumstances A set of concepts that results from or is influenced by criteria or activities associated with the social environment of a person. [NCI] Social Circumstances C165837 C67497 CDISC Glossary software as a medical device (SaMD) Software intended to be used for the performance of one or more medical purposes, without being part of a hardware medical device. [After "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group Date: 18 September 2014] Software as a Medical Device C142690 C67497 CDISC Glossary software validation Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. NOTE: Validating software thus should include evaluation of the suitability of the specifications to "ensure user needs and intended uses can be fulfilled on a consistent basis" (21 CFR 820.20). General Principles of software Validation; Final Guidance for industry and FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a); ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually concerns confirmation that specified requirements have been met, but typically refers to the tracing of requirements and evidence of conformance in the individual phases or modules rather than suitability of the complete product. Validation is, "the evaluation of software at the end of the software development process to ensure compliance with the user requirements" (ANSI/ASQC A3-1978) and should not be thought of as an "end-to-end" verification. See also validation. Software Validation C91996 C67497 CDISC Glossary software verification The process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. NOTE: Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated [After 1. FDA General Principles of Software Validation; 2. ANSI/ASQC A3-1978; 3. ISO/IEC 17025:2017] Device Software Verification Evaluation Method C17146 C67497 CDISC Glossary software Computer programs, procedures, rules, and any associated documentation pertaining to the operation of a system. Computer Program C142752 C67497 CDISC Glossary source data verification The process of ensuring that data that have been derived from source data accurately represent the source data. Source Data Verification C125442 C67497 CDISC Glossary source data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). [ICH E6; CSUCT] Clinical Trial Source Data C142693 C67497 CDISC Glossary source document verification (SDV) The process by which the information reported by an investigator is compared with the source records or original records to ensure that it is complete, accurate, and valid. [Schuyl and Engel, 1999; Khosla et al., Indian J. Pharm 32:180-186, 2000] See also data validation. Source Document Verification C142692 C67497 CDISC Glossary source documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical departments involved in the clinical trial). See also eSource document, source, original data, certified copy. [ICH; CSUICI] Source Document C25683 C67497 CDISC Glossary source The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. NOTE: The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. Accuracy, suitability, and trustworthiness are not defining attributes of "source." The term is also sometimes used as shorthand for source documents and/or source data. [After ICH E6, CSUICI] See also source document, source data, original data, certified copy. Source C18101 C67497 CDISC Glossary special populations Subsets of study populations of particular interest included in clinical trials to ensure that their specific characteristics are considered in interpretation of data (e.g., geriatric). [FDA] Special Population C165838 C67497 CDISC Glossary special purpose domain In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level non-observational domains, which are not classified under the SDTM general observation classes. Examples include trial design domains, relationship domains, etc. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, general observational class. Special Purpose Domain C142694 C67497 CDISC Glossary specified substance Substance defined by groups of elements that describes multi-substance materials or specifies further information on substances relevant to the description of Medicinal Products. NOTE: This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. [After ISO 11615:2017, 3.1.77] Specified Substance C70793 C67497 CDISC Glossary sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor. Clinical Study Sponsor C142695 C67497 CDISC Glossary sponsor-investigator An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator, investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator. Sponsor-Investigator C53322 C67497 CDISC Glossary standard deviation Indicator of the relative variability of a variable around its mean; the square root of the variance. Standard Deviation C94396 C67497 CDISC Glossary standard of care A guideline for medical management and treatment. Best Practice C48443 C67497 CDISC Glossary standard operating procedures (SOPs) Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH] Standard Operating Procedure C142696 C67497 CDISC Glossary standard treatment A treatment currently in wide use and approved by FDA or other health authority, considered to be effective in the treatment of a specific disease or condition. Standard Treatment C81893 C67497 CDISC Glossary standard technical standard A repeatable written norm, pattern, or model that is generally accepted by agreement, established or approved by an authority, or widely accepted and used by custom. [After https://dictionary.cambridge.org/us/dictionary/english/standard, https://www.fda.gov/media/124694/download]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization. Standard C165839 C67497 CDISC Glossary Standards Development Organization (SDO) A domestic or international organization that plans, develops, establishes, or coordinates standards by using procedures that incorporate the attributes of openness, balance of interests, due process, an appeals process, and consensus. [After Office of Management and Budget (OMB) Circular A-119]. See also standard, data standards, CDISC standards, and Study Data Standardization Plan. Standards Development Organization C115761 C67497 CDISC Glossary statistical analysis plan A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. [ICH E9] Statistical Analysis Plan C53206 C67497 CDISC Glossary statistical distribution A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style] Statistical Distribution C19044 C67497 CDISC Glossary statistical method The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998] Statistical Technique C61040 C67497 CDISC Glossary statistical significance The likelihood that an event occurs by chance (e.g., hypothesis is rejected). Whether or not a given result is significant depends on the significance level adopted. NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it. Statistical Significance C142628 C67497 CDISC Glossary stem The prompt, question, or instruction in a PRO item. See also response option, item. Patient Reported Outcome Stem C142697 C67497 CDISC Glossary stochastic Involving a random variable; involving chance or probability. Stochastic C142698 C67497 CDISC Glossary stopping rules A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary. Stopping Rules C25689 C67497 CDISC Glossary stratification Grouping defined by important prognostic factors measured at baseline. [ICH E9] Stratification C142699 C67497 CDISC Glossary structured data Data that have been organized into discrete fields, and may be enumerated, numeric, or codified. Structured Data C184388 C67497 CDISC Glossary structured health record information Structured health record information is organized into discrete fields, and may be enumerated, numeric, or codified. Examples of structured health information include: patient address (non-codified, but discrete field); diastolic blood pressure (numeric); coded result observation; coded diagnosis; patient risk assessment questionnaire with multiple-choice answers. Context may determine whether or not data are unstructured, e.g., a progress note might be standardized and structured in some eHR-s (e.g., subjective/objective/ assessment/Plan) but unstructured in others. [HL7 eHR-s FM Glossary of Terms, 2010]. Structured Health Record Information C142700 C67497 CDISC Glossary structured product label (SPL) The structured product labeling (SPL) specification is an HL7 ANSI-approved document markup standard that specifies the structure and semantics for the exchange of product information. [HL7] Structured Product Labeling C142702 C67497 CDISC Glossary study completion date The date on which the final data for a clinical study were collected because the last study participant made the final visit to the study location (that is, last subject, last visit, or as otherwise defined in the study protocol). NOTE: See also study completion date data element on ClinicalTrials.gov. Study Completion Date C70756 C67497 CDISC Glossary study completion As defined in the protocol, the point at which all protocol-required activities have been executed. NOTE: According to EU CTR, this should be a clear and unambiguous definition of the end of the clinical trial in question and, if it is not the date of the last visit of the last subject, a specification of the estimated end date and a justification thereof should be included. [REGULATION (EU) No 536/2014 Article 2.26] Study Completed C165840 C67497 CDISC Glossary Study Data Standardization Plan (SDSP) A document that describes the data standardization strategy for clinical and nonclinical studies within a development program. NOTE: A Study Data Standardization Plan is intended to include historical, current, and planned information about the use of study data standards for studies to conform with the current technical formats, and terminologies described in the FDA Data Standards Catalog which applies to CDER, CBER, and CDRH. [After http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf, https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources, https://www.fda.gov/media/102719/download] See also standards, data standards, CDISC standards, and Standards Development Organization. Study Data Standardization Plan C142704 C67497 CDISC Glossary study description Representation of key elements of study (e.g., control, blinding, gender, dose, indication, configuration). Study Description C142705 C67497 CDISC Glossary study design rationale Reason(s) for choosing the study design. NOTE: Reasons may include the choice of control, comparator or population, as well as the scientific or statistical rationale. Study Design Rationale C93682 C67497 CDISC Glossary study design schematic A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. [CDISC Terminology; After ICH E3] Study Schematic C15320 C67497 CDISC Glossary study design Plan for the precise procedure to be followed in a clinical trial, including planned and actual timing of events, choice of control group, method of allocating treatments, blinding methods; assigns a subject to pass through one or more epochs in the course of a trial. specific design elements (e.g., crossover, parallel, dose-escalation) [Modified from Pocock, Clinical Trials: a Practical approach] See Trial Design Model. See also, arm, epoch, and visit. Study Design C142707 C67497 CDISC Glossary study monitoring Trial Monitoring The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring. Study Monitoring C142710 C67497 CDISC Glossary study participant A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, data subject, clinical research subject, participant. Study Participant C70833 C67497 CDISC Glossary study population A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. (CDISC Protocol Entities) Study Population C142711 C67497 CDISC Glossary study publication date The date of the publication of scientific articles or abstracts about a clinical study. NOTE: Institute of Medicine (IOM) Report: The committee noted support for open and free access to scientific publications immediately upon publication, as well as the requirement of the U.S. Food and Drug Administration (FDA) to make a summary of clinical trial results available to the public. [ClinicalTrials.gov] Study Publication Date C142713 C67497 CDISC Glossary study report completion date The date at which the study report is considered final and will not be subject to any further change prior to submission. NOTE: For interventional studies of adults the study report completion date should be one year from the end of the LPLV, or end of study; for pediatric interventional studies this date should be six months. For non-interventional studies the study report completion date should be one year from the end of the LPLV, end of study, or end of data collection. [EU CTR] Study Report Completion Date C69208 C67497 CDISC Glossary study start date The date on which the protocol-defined study start criteria are met. NOTE: The US FDA defines the study start date for clinical studies as the earliest date of informed consent among any subject that enrolled in the study. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] Study Start Date C142714 C67497 CDISC Glossary study start The criteria for study start, as defined in the protocol, are met. Study Start C142192 C67497 CDISC Glossary study variable A term used in trial design to denote a variable to be captured on the CRF. See also variable. Study Variable C54622 C67497 CDISC Glossary sub-investigator Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [After ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator. Subinvestigator C70735 C67497 CDISC Glossary subject completion The case where a subject ceases active participation in a trial because the subject has, or is presumed to have followed all appropriate conditions of a protocol. Subject Completed Participation in Study C142717 C67497 CDISC Glossary subject data event A subject visit or other encounter where subject data are collected, generated, or reviewed. [SDTM] Subject Data Event C70731 C67497 CDISC Glossary subject identification code A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. [ICH] Clinical Trial Subject Unique Identifier C156639 C67497 CDISC Glossary subject monitoring Act of tracking, reporting, and review of a clinical trial subject's status and/ or performance of required activities per protocol. NOTE: Examples include monitoring compliance with treatment and scheduled tasks, tracking measures of symptoms, self reported feelings, and/or behaviors. Subject monitoring supports managing of patient safety and well being by site staff as defined in a protocol. Compare with medical device, medical monitoring. Subject Monitoring C142638 C67497 CDISC Glossary subject trial contact Any activity, anticipated in the study protocol, involving a subject and pertaining to collection of data. See visit. Planned Trial Subject Contact C21089 C67497 CDISC Glossary subject-reported outcome (SRO) An outcome reported directly by a subject in a clinical trial. [Patrick, D.l., 2003] See also patient-reported outcome (PRO). Patient Self-Report C142496 C67497 CDISC Glossary submission model A set of data standards (including SDTM, ADaM, and define.xml) for representing data that are submitted to regulatory authorities to support product marketing applications. NOTE: CDISC submission data consist of: tabulations that represent the essential data collected about patients; analysis data structured to support analysis and interpretation; and metadata descriptions. Data Submission Model C142722 C67497 CDISC Glossary superiority trial A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). [ICH E9] Superiority Trial C142459 C67497 CDISC Glossary supplier (system) An organization that enters into a contract with the acquirer for the supply of a system (such as a software product, or software service) under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30] Computer System or Software Supplier C68772 C67497 CDISC Glossary surrogate endpoint An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource]. See also endpoint. Surrogate Endpoint C142724 C67497 CDISC Glossary surrogate marker A measurement of a drug's biological activity that substitutes for a clinically meaningful endpoint. [After Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, NeuroRx. 2004 Apr;1(2):189-95.] Surrogate Marker C142725 C67497 CDISC Glossary surrogate variable A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. [ICH E9] Surrogate Variable C17176 C67497 CDISC Glossary survey Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect PRO data. NOTE: survey refers to the content of the group of items and does not necessarily include the training and scoring documents generally not seen by respondents. [from ISOQOL comments on PRO Guidance] Compare to instrument. Survey C156631 C67497 CDISC Glossary suspension (of a clinical trial) An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial). Clinical Trial Suspension C4876 C67497 CDISC Glossary symptom An experience reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign. Symptom C68836 C67497 CDISC Glossary synopsis Brief overview prepared at the conclusion of a study as a routine part of a regulatory submission, summarizing the study plan and results; includes numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc. [after ICH E3] Synopsis C54277 C67497 CDISC Glossary syntactic The order, format, content of clinical trial data and/or documents as distinct from their meaning. NOTE: Syntactic interoperability is achieved when information is correctly exchanged between two systems according to structured rules whether or not sensible meaning is preserved. See also semantic, semantic interoperability. Syntax C176263 C67497 CDISC Glossary synthetic data Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence. Synthetic Data C25700 C67497 CDISC Glossary system People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI] System C53231 C67497 CDISC Glossary t-test A statistical test used to compare the means of two groups of test data. t-Test C125429 C67497 CDISC Glossary table of roles and responsibilities A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials. Clinical Trial Roles and Responsibilities Matrix C142727 C67497 CDISC Glossary tabulation dataset A dataset structured in a tabular format. NOTE: The CDISC Study Data Tabulation Model (SDTM) defines standards for tabulation datasets that fulfill FDA requirements for submitting clinical trial data. Tabulation Dataset C49692 C67497 CDISC Glossary target enrollment The number of subjects in a cohort and in the entire study intended to be enrolled to reach the planned sample size. NOTE: Target enrollments are set by sample size calculations so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by algorithm or other specified process. [After ICH E9; After clinicaltrials.gov] See also sample size. Planned Subject Number C142728 C67497 CDISC Glossary target population Population of patients to which the indication of a medicinal product applies. NOTE: The term applies to investigational and authorized medicinal products. [After ISO 11615.2012] Target Study Population C142729 C67497 CDISC Glossary technology provider technology vendor A person, company, or other entity who develops, produces, and sells software applications and/or hardware for use in conducting clinical trials and/or in analyzing clinical trial data and or submitting clinical trial information for regulatory approval. Technology Provider C156630 C67497 CDISC Glossary temporary halt (of a clinical trial) An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial). Clinical Trial Temporary Halt C45559 C67497 CDISC Glossary term One or more words designating something. NOTE: In a controlled vocabulary, terms are considered to refer to an underlying concept having a single meaning. Concepts may be linked to several synonymous terms. Term C142739 C67497 CDISC Glossary termination (of a clinical trial) Discontinuation of a trial prior to plan as defined in the protocol. NOTE: Additional information can be found in Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual: Premature Termination or Suspension of a Clinical Trial, 19 January 2021. See also discontinuation, suspension (of a clinical trial), clinical hold (of a clinical trial), temporary halt (of a clinical trial). Trial Termination C142730 C67497 CDISC Glossary terminology Set of concepts, designations, and relationships for a specialized subject area. NOTE: In the context of clinical research in human subjects, a standardized, finite set of terms (e.g., CDISC Terminology, MedDRA codes) that denote patient findings, circumstances, events, and interventions. See also glossary, vocabulary. Contrast with nomenclature. Terminology C101302 C67497 CDISC Glossary therapeutic area A category for a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention. (After NCI) Therapeutic Area C18223 C67497 CDISC Glossary therapeutic index The ratio of the dose that produces toxicity (denominator) to the dose that produces a clinically desired or effective response (numerator). NOTE: The therapeutic index is a measure of a drug's safety, because a larger value indicates a wide margin between doses that are effective and doses that are toxic. [After Finkel, R, Clark, M. A., Champe, P. C. & Cubeddu, L. X. (eds) Lippincott's Illustrated Reviews: Pharmacology 4th edn (Lippincott Williams & Wilkins, 2008).] Therapeutic Index C67478 C67497 CDISC Glossary token Physical key that provides access to a secure electronic system or location. Token C165841 C67497 CDISC Glossary traceability (data) The ability to track data from source data collection through final use in reporting or analysis to ensure data interoperability, integrity, and interpretability. See also data integrity. Data Traceability C142497 C67497 CDISC Glossary transcription Process of transforming dictated or otherwise documented information from one storage medium to another. NOTE: often refers explicitly to data that is manually transcribed from source docs or measuring devices to CRFs or to eCRFs. Data Transcription C82567 C67497 CDISC Glossary transition rule A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan. See branch. Transition Rule C80450 C67497 CDISC Glossary translation Converting information from one natural language to another while preserving meaning. Compare to mapping. Translation C15862 C67497 CDISC Glossary translational research The multidirectional integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. NOTE: These studies are designed to translate basic science findings into clinically useful tools and applications and to ensure that new treatments and research knowledge reach the patients or populations for whom they are intended and are implemented correctly. [After Rubio DM, Schoenbaum EE, Lee LS, Schteingart DE, Marantz PR, Anderson KE, Platt LD, Baez A, Esposito K. Defining translational research: implications for training. Acad Med. 2010 Mar;85(3):470-5. and NCI Thesaurus] Translational Research C142499 C67497 CDISC Glossary transmit To transfer data, usually electronically. NOTE: In eClinical investigations data are commonly transmitted from subjects to clinical study sites, within or among clinical study sites, contract research organizations, data management centers, and sponsors, or to regulatory authorities. [modified from CSUICI]. Data Transmission C142731 C67497 CDISC Glossary treatment benefit The impact of treatment as measured by survival or a COA of how patients feel or function. Direct evidence of treatment benefit is derived from clinical trial effectiveness endpoints that measure survival or a meaningful aspect of how a patient feels or functions in daily life. NOTE: Treatment benefit can be demonstrated by an advantage in either effectiveness or safety, or both. [After FDA Clinical Outcome Assessment (COA) Glossary] Treatment Benefit C49236 C67497 CDISC Glossary treatment therapy Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis. Therapeutic Procedure C142733 C67497 CDISC Glossary treatment-emergent adverse event An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. [ICH E9] Treatment-Emergent Adverse Event C142735 C67497 CDISC Glossary trial design element A basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.[CDISC PRM Project] See also epoch. Trial Design Element C142736 C67497 CDISC Glossary Trial Design Model Defines a standard structure for representing the planned sequence of events and the treatment plan of a trial. NOTE: A component of the SDTM that builds upon elements, arms epochs, visits; suitable also for syntactic interpretation by machines. [CDISC] See study design. Trial Design Model C85838 C67497 CDISC Glossary trial site The location at which clinical trial activities are conducted. NOTE: Synonym for investigative site, investigator site, site, site of the trial, study site. [ICH E6 (R2)] Clinical Trial Site C142737 C67497 CDISC Glossary trial statistician A statistician who has a combination of education/ training and experience sufficient to implement the principles in the ICH E9 guidance and who is responsible for the statistical aspects of the trial. [ICH E9] Trial Statistician C66959 C67497 CDISC Glossary triple-blind study A study in which knowledge of the treatment assignment(s) is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators. Triple Blind Study C142740 C67497 CDISC Glossary trustworthy (electronic records) An attribute of records (data and documents) and signatures submitted to regulatory agencies referring to their suitability for making scientific findings of safety and efficacy that underlie public policy decisions pertaining to market authorization. Two key dimensions that determine the trustworthiness of eClinical trial data are data quality and data integrity. [after 21CFR Part 11] Trustworthy Electronic Record C45726 C67497 CDISC Glossary type 1 (or type I) error false positive Error made when a null hypothesis is rejected but is actually true. False Positive C93283 C67497 CDISC Glossary type 2 (or type II) error false negative Error made when an alternative hypothesis is rejected when it is actually true. False Negative C142741 C67497 CDISC Glossary type 3 (or type III) error Some statisticians use this designation for an error made when calling the less effective treatment the more effective treatment. Type 3 Error C142576 C67497 CDISC Glossary type of comparison How treatment arms will be compared (e.g., safety, efficacy, PK/PD). May also include comparison to data from other studies or sources (e.g., historical control). [ICH E9, EudraCT (p.18)] ICH Type Of Comparison C202589 C67497 CDISC Glossary umbrella trial design A type of trial design under a master protocol designed to evaluate multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022]. See also master protocol. Umbrella Trial Design C142742 C67497 CDISC Glossary unblinding Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023] Unblinding C142744 C67497 CDISC Glossary unexpected adverse drug reaction An adverse drug reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information (e.g., IB for an unapproved investigational product or PI/summary of product characteristics for an approved product, and/or scientific literature). [After ICH E6 (R2)] Unexpected Adverse Drug Reaction C142745 C67497 CDISC Glossary unexpected serious risk A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)] Unexpected Serious Risk C42743 C67497 CDISC Glossary uniform resource locator (URL) Address of a web page, for example, appliedclinicaltrialsonline.com. Uniform Resource Locator C81930 C67497 CDISC Glossary use case An explicit scenario designed to help in determining whether a system/process is capable of performing the functions required for a particular use. a use case might describe, for example, how a study coordinator would use a tablet computer to capture medical history data. Use Case C156628 C67497 CDISC Glossary use error (device) User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm. [FDA, Applying Human Factors and Usability Engineering to Medical Devices] Device Use Error C142746 C67497 CDISC Glossary user site testing (UST) Any testing that takes place outside of the developer's controlled environment. NOTE: Terms such as beta test, site validation, user acceptance test, installation verification, and installation testing have all been used to describe user site testing. User site testing encompasses all of these and any other testing that takes place outside of the developer's controlled environment. [from General Principles of software Validation; Final Guidance, section 5.2.6] User Site Testing C184385 C67497 CDISC Glossary vaccine effectiveness Vaccine protection measured in observational studies that include people with underlying medical conditions who have been administered vaccines by different health care providers under real-world conditions. [How Flu Vaccine Effectiveness and Efficacy are Measured, Questions & Answers, CDC January 29, 2016] See also vaccine efficacy, efficacy, effectiveness, randomized controlled trial (RCT). Vaccine Effectiveness C184384 C67497 CDISC Glossary vaccine efficacy The proportional comparison of infection rate or other disease endpoints between vaccinated and unvaccinated groups measured in randomized controlled trials. NOTE: The method for calculating vaccine efficacy can be found here: https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section6.html. Efficacy is a measurement made during a clinical trial, effectiveness is how well the vaccine works out in the real world. [After Greenwood et al., Proc R Soc Med. 1915; 8 (Sect Epidemiol State Med): 113-194, The Statistics of Anti-typhoid and Anti-cholera Inoculations, and the Interpretation of such Statistics in general. After Piero Ollario, The Lancet Infectious Diseases, Feb 17th, 2021] See also vaccine effectiveness, effectiveness, efficacy, randomized controlled trial (RCT). Vaccine Efficacy C923 C67497 CDISC Glossary vaccine A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). NOTE: The vaccines against infectious disease may contain various ingredients of diverse origin (such as inactivated or attenuated organisms, particular antigens related to the infectious agent, live recombinant vector against antigens in vivo and adjuvants) [After NCI Dictionary of Cancer Terms. After European Pharmacopoeia section 5.1.] See also treatment, prevention, prophylaxis, biological product, virulence. Vaccine C71756 C67497 CDISC Glossary valid Sound Well grounded on principles of evidence. [After FDA Glossary of Computerized System and Software Development Terminology] Valid C16237 C67497 CDISC Glossary validation validity Process of establishing suitability to purpose. NOTE: Validation is accomplished by planning how to measure and/or evaluate suitability to purpose; then executing the plan and documenting the results. [ICH E6] See also software validation, data validation, psychometric validation, criterion validation (COA), content validation (COA), construct validation (COA). Validation C54166 C67497 CDISC Glossary variable Any attribute, phenomenon, characteristic, or event that can have different qualitative or quantitative values. [After Statistical Language - What are Variables?, Australian Bureau of Statistics, October 2013] See also dependent variable, derived variable, global assessment variable, primary outcome variable, qualitative variable, quantitative variable, secondary outcome variable, study variable, supporting variables, surrogate variable. Variable C48918 C67497 CDISC Glossary variance A measure of the variability in a sample or population. It is calculated as the mean squared deviation (MSD) of the individual values from their common mean. In calculating the MSD, the divisor n is commonly used for a population variance and the divisor n-1 for a sample variance. Variance C142501 C67497 CDISC Glossary verification of data The checking of data for correctness or compliance with applicable standards, rules, and conventions. [FDA Glossary of Computerized system and software Development Terminology] See also source document verification (SDV). Data Verification C45513 C67497 CDISC Glossary verification The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements. Compare to validation where suitability to purpose is also established. Verification C176264 C67497 CDISC Glossary virtual Connected but not physically co-located. NOTE: Refers to visits or encounters between investigators and subjects where information exchange is mediated through telemedicine, video conference rather than by physical presence of individuals at a shared location. Trials with one or more virtual visits are virtual trials. Where all data capture and trial procedures are conducted virtually, a trial or other investigation may be called fully virtual. [After FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards March 2020 Updated on July 2, 2020] See also remote clinical trial, decentralized clinical trial. Virtual C28198 C67497 CDISC Glossary virulence The ability of an infectious agent to cause severe disease, measured as the proportion of persons with the disease who become severely ill or die. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014] See also morbidity, vaccine. Virulence C191214 C67497 CDISC Glossary visit Study Visit A protocol-defined clinical encounter that encompasses planned and contingent study interventions, procedures, and assessments that may be performed on a subject. [SDTM] Study Visit C92442 C67497 CDISC Glossary vocabulary The collection of terms, which refer to concepts, that are used by, understood by, or available for use by an individual or group within a language system. [After NCI Thesaurus] Vocabulary C142747 C67497 CDISC Glossary vulnerable subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [After ICH E6 R2 Glossary] See also human subject, patient, human subject, data subject, clinical research subject, participant, study participant. Vulnerable Subjects C142556 C67497 CDISC Glossary Warning Letter A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice. [FDA] FDA Warning Letter C42872 C67497 CDISC Glossary washout period A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated). Washout Period C142748 C67497 CDISC Glossary web browser A computer program that interprets HTML and other Internet languages and protocols and displays web pages on a computer monitor. Web Browser C142749 C67497 CDISC Glossary web page A single page on a website, such as a home page. Web Page C142750 C67497 CDISC Glossary web server A computer server that delivers HTML pages or files over the World Wide Web. See also server. Web Server C67518 C67497 CDISC Glossary website A collection of web pages and other files. A site can consist of a single web page, thousands of pages, or custom created pages that draw on a database associated with the site. Web Site C48192 C67497 CDISC Glossary weighting An adjustment in a value based on scientific observations within the data. Importance Weight C142720 C67497 CDISC Glossary well-being (of the trial subjects) The physical and mental integrity of the subjects participating in a clinical trial. [ICH] Subject Well-Being C49634 C67497 CDISC Glossary withdrawal The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, September 21, 2010] See also discontinuation. Withdrawal by Subject C67498 C67497 CDISC Glossary within-subject differences In a crossover trial, variability in each subject is used to assess treatment differences. Intra Subject Variability C20461 C67497 CDISC Glossary World Wide Web All the resources and users on the Internet that are using HTTP protocols. Also called the web and www. World Wide Web C45967 C67497 CDISC Glossary XML (eXtensible Markup Language) A set of rules for encoding documents and data in a format that is both human readable and machine readable. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019; After W3C Extensible Markup Language (XML)] See also eXtensible markup language (XML) data element, Define-XML. Extensible Markup Language C35803 C67497 CDISC Glossary zoonosis An infectious disease that is transmissible from animals to humans. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014] Zoonotic Infection