| CodeList |
| CodeListItem |
| NCI attributes |
| C67497 | CDISC Glossary |
| OID | Name (CDISC Submission Value) | DataType Extensible | NCI Code | CDISC Synonym | CDISC Definition | Preferred Term |
|---|---|---|---|---|---|---|
| CDISC Submission Value [ODM:CodedValue] | ||||||
| CL.C67497.CDISC Glossary | CDISC Glossary (CDISC Glossary) | text Extensible: NA | C67497 | CDISC Glossary | The terminology of the Clinical Data Interchange Standards Consortium (CDISC) glossary. | CDISC Glossary Terminology |
| 510(k) | C80442 | 510(k). Premarket Notification (PMN) required for certain medical devices. See http://www.fda.gov/cdrh/510khome.html. | Premarket Device Notification | |||
| abbreviation | C42610 | 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 | |||
| absorption | C71733 | 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 | |||
| accelerated approval | C156638 | 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 | ||
| acronym | C93495 | 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 | |||
| action letter | C142550 | 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 | |||
| activation (EDC) | C142528 | Enabling an eClinical trial system to capture data; usually used for EDC systems. | Electronic Data Capture Activation | |||
| active ingredient | C82533 | An active ingredient is 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 | |||
| active ingredient dose | C95337 | active substance dose | The amount of a single active substance administered in a single dose. | Active Ingredient Dose | ||
| adaptive design | C98704 | A study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. [FDA, Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics] | Adaptive Design | |||
| adequate and well-controlled studies | C142382 | 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 | |||
| administrable dosage form | C142383 | 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 | |||
| administration (substance) | C25409 | The act of introducing a substance into or onto the body. See also route of administration, administrable dosage form. | Administration | |||
| admission criteria | C142384 | 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 | |||
| adverse drug reaction (ADR) | C142385 | 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 | ||
| adverse event (AE) | C41331 | 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 | ||
| adverse reaction | C41332 | 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 | |||
| AEGIS (ADROIT Electronically Generated Information Service) | C156645 | 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 | |||
| AHIC (American Health Information Community) | C156646 | 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 | |||
| ALCOA | C156621 | 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 | |||
| ALCOA + | C156622 | 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 | ||
| alert | C142753 | 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 | |||
| algorithm | C16275 | 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 | |||
| alpha error | C142387 | 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 | |||
| amendment | C41200 | A written description of a change(s) to, or formal clarification of, a protocol. | Amendment | |||
| American National Standards Institute (ANSI) | C142388 | 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 | |||
| analysis dataset | C142389 | 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 | |||
| analysis set | C142390 | 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 | |||
| analysis variables | C142391 | Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. [PR Project] See also variable. | Analysis Variable | |||
| anchor | C142436 | 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 | |||
| anonymization | C142392 | 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 | |||
| anticipated adverse event | C156629 | 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 | |||
| applet | C142393 | A small application, typically downloaded from a server. | Applet | |||
| applicable regulatory requirement(s) | C142394 | Any law(s) or regulation(s) addressing the conduct of clinical trials of investigational products. [ICH E6(R2) Glossary, 1.4] | Applicable Regulatory Requirement | |||
| approvable letter | C142551 | 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 | |||
| approval (in relation to Institutional Review Boards) | C70800 | 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 | |||
| approval letter | C70799 | 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 | |||
| arm (protocol) | C15538 | 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 | |||
| assessment | C25217 | A measurement, evaluation, or judgment for a study variable pertaining to the status of a subject. NOTE: Assessments are usually measured at a certain time, and usually are not compounded significantly by combining several simultaneous measurements to form a derived assessment (e.g., BMI) or a result of statistical analysis. The term assessment is intended to invoke some degree of evaluation or judgment concerning subject status. Refer to COA glossary of terms. See also variable, outcome, endpoint. [After Clinical Outcome Assessment (COA) Glossary of Terms FDA FDA eCOA Glossary] | Assessment | |||
| attributable | C25358 | 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 | |||
| attribute (n) | C62618 | In data modeling, refers to specific items of data that can be collected for a class. | Computer Programming Object Attribute | |||
| audit | C45269 | 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 | |||
| audit certificate | C115469 | 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 | |||
| audit report | C142395 | A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary] | Audit Report | |||
| audit trail | C142396 | 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 | |||
| authorised auxiliary medicinal product | C156618 | 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 | |||
| authorised investigational medicinal product | C156617 | 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] | Authorized Investigational Medicinal Product | |||
| authorization | C41192 | 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 | |||
| auxiliary medicinal product | C156473 | 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 | |||
| back translation (natural language) | C142397 | 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 | |||
| background material | C142649 | 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. [PR Project] | Protocol Background Material | |||
| background treatment | C165822 | 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 | |||
| balanced study | C142398 | Trial in which a particular type of subject is equally represented in each study group. | Balanced Study | |||
| bandwidth | C142399 | 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 | |||
| baseline assessment | C142400 | Assessment of subjects as they enter a trial and before they receive any treatment. | Baseline Assessment | |||
| baseline characteristics | C142401 | 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 | |||
| baseline imbalance | C142402 | 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 | |||
| basket protocol | C165823 | A type of 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 FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and 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.] See also master protocol. | Basket Protocol | |||
| Bayesian approaches | C142403 | 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 | |||
| Bayesian statistics | C142404 | 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 | |||
| beta error | C142405 | 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 | |||
| bias | C28232 | 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 | |||
| bioanalytical assays | C16341 | Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids. | Bioassay | |||
| bioavailability | C70913 | Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body. | Bioavailability | |||
| bioequivalence | C71763 | 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 | |||
| Biologics licensing application (BLA) | C71778 | Biologics licensing application (BLA). an application to FDA for a license to market a new biologic product in the United states. | Biologics License Application | |||
| biomarker | C16342 | 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 | ||
| biometric signature | C142406 | 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 | |||
| biosimilar | C156644 | 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 | |||
| biostatistics | C16347 | Branch of statistics applied to the analysis of biological phenomena. | Biostatistics | |||
| blind review | C142407 | Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis. [Modified ICH E9] | Blind Review | |||
| blinded (masked) medications | C142408 | 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 | |||
| blinded study | C70840 | 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 | |||
| blinding | C49068 | masking | 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. NOTE: Masking, while often used synonymously with blinding, usually denotes concealing the specific study intervention used. [After ICH E6 (R2) Glossary, 1.10]. The term masking is often preferred to blinding in the field of ophthalmology. [from AMA Manual of Style]. See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study. | Blinded | ||
| branch | C142701 | Point within a study design where there is an allocation of subject subsets to particular procedures or treatment groups. | Study Branch | |||
| browser | C80012 | 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 | |||
| cache | C63626 | Storage area on a computer's hard drive where the browser stores (for a limited time) web pages and/or graphic elements. | Memory Cache | |||
| carry-over effect | C142409 | Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity. | Carry-Over Effect | |||
| case history | C142588 | 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 | |||
| case report form (CRF) | C40988 | 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 | ||
| case report tabulations (CRT) | C142411 | 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 | |||
| categorical data | C142412 | Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories. | Categorical Data | |||
| causality assessment | C142413 | 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 | |||
| CDISC SHARE | C142415 | 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. In the first iteration, CDISC SHARE will contain the existing CDISC standards, such as CDASH and SDTM, providing machine-readable elements (variables) within those standards. This will allow a range of applications used within organizations to automatically access those definitions. [CDISC] | CDISC Shared Health And Research Electronic Library | |||
| CDISC standards | C142416 | 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 | |||
| certified copy | C142417 | 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 | |||
| certified IRB professional (CIP) | C142418 | 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 | |||
| challenge agent | C158128 | 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 | |||
| CHI (consolidated health informatics) | C156647 | 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 | |||
| class | C41106 | 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 | |||
| clean database | C142419 | 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 | |||
| clean file | C142420 | When all data cleaning is completed and database is ready for quality review and unblinding. | Clean File | |||
| client | C142421 | 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 | |||
| clinical benefit | C142422 | 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 | |||
| clinical clarification | C142423 | A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.). See also self-evident change. | Clinical Clarification | |||
| clinical data | C15783 | 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 | |||
| clinical development plan | C142424 | 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 | |||
| clinical document | C142425 | 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 | |||
| clinical document architecture | C142426 | Specification for the structure and semantics of "clinical documents" for the purpose of exchange. [HL7; SPL] | Clinical Document Architecture | |||
| clinical efficacy | C39547 | Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans. [SQA] | Treatment Efficacy | |||
| clinical encounter | C142427 | 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 | |||
| clinical hold (of a clinical trial) | C70755 | 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] | Study on Hold | |||
| clinical investigation | C142430 | 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 | |||
| clinical outcome assessment (COA) | C142378 | 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 | |||
| clinical outcome assessment (COA) qualification | C142552 | 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 | |||
| clinical pharmacology | C16975 | 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 | |||
| clinical protocol | C25320 | See protocol. | Clinical Study Protocol | |||
| clinical research and development | C142435 | 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 | |||
| clinical research associate (CRA) | C25465 | 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 | |||
| clinical research coordinator (CRC) | C51811 | clinical coordinator;research coordinator;study coordinator;trial coordinator | Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor's visit. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator | Clinical Coordinator | ||
| clinical research subject | C70668 | A person who is enrolled into a clinical study or trial. See also study, trial, and study population. | Clinical Study Subject | |||
| clinical significance | C82562 | 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 | |||
| clinical study | C15206 | 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 | |||
| clinical study (trial) report | C142439 | 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 | |||
| clinical study data element | C142437 | 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 | |||
| clinical trial | C71104 | 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. | Clinical Trial | |||
| clinical trial authorization | C142440 | 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 | |||
| clinical trial data | C142441 | Data collected in the course of a clinical trial. See also clinical trial information. | Clinical Trial Data | |||
| clinical trial exemption (CTX) | C142446 | 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 | |||
| clinical trial information | C142447 | 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 | |||
| clinical trial materials | C142449 | Complete set of supplies provided to an investigator by the trial sponsor. | Clinical Trial Material | |||
| clinical trial registry | C142452 | 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 | |||
| clinical trial results registry | C156620 | A web-based publicly accessible platform for providing structured summary results information about clinical trials. See also clinical trial registry. | Clinical Trial Results Registry | |||
| clinician-reported outcome (ClinRO) | C142453 | 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 | |||
| Cmax | C70918 | Used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug. | Cmax | |||
| co-packaged product | C165824 | 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 | |||
| codelist | C142454 | Finite list of codes and their meanings that represent the only allowed values for a data item. See also controlled vocabulary. A codelist is one type of controlled vocabulary. | Codelist | |||
| coding | C80216 | In clinical trials, the process of assigning data to categories for analysis NOTE: Adverse events, for example, may be coded using MedDRA. | Encode | |||
| cognitive debriefing | C142455 | 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 | |||
| cohort | C61512 | 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 | |||
| cohort study | C15208 | 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. [AMA Manual of Style] See also prospective study. | Cohort Study | |||
| combination product | C54696 | 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 | |||
| commercially confidential information (CCI) | C142456 | 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 | |||
| common data element (CDE) | C19984 | 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 | |||
| Common Technical Document | C142575 | 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 | |||
| comparative study | C142457 | One in which the investigative drug is compared against another product, either active drug or placebo. | Comparative Study | |||
| comparator (product) | C142458 | 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 | |||
| Competent Authority (CA) | C142544 | The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States. | European Union Competent Authority | |||
| compliance (in relation to trials) | C142734 | Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. [Modified ICH E6 Glossary] | Trial Compliance | |||
| computer application | C42608 | application software | Software designed to fill specific needs of a user; for example, software for navigation, project management, or process control. | Computer Application | ||
| concept | C45728 | 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 | |||
| concept of interest | C142433 | 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 | |||
| concerned member state (CMS) | C156640 | 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 | |||
| confidence interval (CI) | C53324 | 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 | |||
| confidentiality | C16466 | Prevention of disclosure to other than authorized individuals of a sponsor's proprietary information or of a subject's identity. [ICH E6 Glossary] | Confidentiality | |||
| confirmatory trial | C142460 | 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. Compare to exploratory trial. | Confirmatory Trial | |||
| conformity assessment | C142461 | The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body. | Conformity Assessment | |||
| consent form | C16468 | 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. See also informed consent. | Consent Form | ||
| construct validation (COA) | C156633 | Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment 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/] | Clinical Outcome Assessment Construct Validation | |||
| consumer safety officer (CSO) | C142462 | FDA official who coordinates the review process of various applications. | Consumer Safety Officer | |||
| content validation (COA) | C156632 | Establishing from qualitative research the extent to which the clinical outcome assessment 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/] | Clinical Outcome Assessment Content Validation | |||
| content validity | C78690 | 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 | |||
| context of use | C142434 | 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 | |||
| contingent subject trial contact | C142463 | Planned response to an anticipated but conditional event in a clinical trial. [CDISC Trial Design Project] | Contingent Subject Trial Contact | |||
| contract | C115464 | 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 | |||
| contract research organization (CRO) | C54148 | 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 | |||
| control | C142703 | In a trial, a comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol). | Study Control | |||
| control (of electronic records) | C142464 | To prepare and maintain case histories and other records for regulated clinical investigations. 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] | Control of Electronic Records | |||
| control group | C28143 | 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 | |||
| control of electronic records | C142532 | Processes or operations intended to ensure authenticity, integrity, and confidentiality of electronic records. NOTE: The protocol incorporates scientific rationale for selection of comparator and describes how the comparator serves as a reference point for the evaluation. SDTM provides a codelist for type of control. [After 21 CFR 11; CSUCT] | Electronic Records Control | |||
| controlled study | C28279 | 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 | |||
| controlled vocabulary | C48697 | 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 | ||
| coordinating committee | C142465 | A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. [ICH E6] | Coordinating Committee | |||
| coordinating investigator | C51818 | 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 | |||
| correlation | C48834 | 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; ADaM] | Correlation | |||
| covariate (prognostic) | C142645 | Factor or condition that influences outcome of a trial. [ADaM] | Prognostic Covariate | |||
| CRF (paper) | C142625 | 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 | |||
| CRF data | C142410 | Subset of clinical trial data that are entered into fields on a CRF. | Case Report Form Data | |||
| criterion validation (COA) | C156634 | 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, 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/] | Clinical Outcome Assessment Criterion Validation | |||
| cross-labeled product | C165825 | 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 | |||
| crossover trial | C82637 | 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. [Center for the advancement of Clinical Research; ADaM] | Crossover Study | |||
| CTCAE (Common Terminology Criterion for Adverse Events) | C49704 | Standard terminology developed to report adverse events occurring in cancer clinical trials. CTCAE are used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI) | Common Terminology Criteria for Adverse Events | |||
| CUI (common unique identifier) | C70818 | A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms. | Concept Unique Identifier | |||
| curriculum vitae (CV) | C54631 | Document that outlines a person's educational and professional history. | Curriculum Vitae | |||
| data | C25474 | Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA] | Data | |||
| data acquisition | C142469 | 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 | |||
| data capture | C142470 | See data entry. | Data Capture | |||
| data clarification | C142471 | 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 | |||
| data clarification form | C115521 | A form used to query an investigator and collect feedback to resolve questions regarding data. | Data Clarification Form | |||
| data collection | C103159 | 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 | |||
| data collection instrument | C142472 | A substrate or tool (either electronic or paper) used to record, transcribe, or collect clinical data. [PR Project] | Data Collection Instrument | |||
| data element | C41002 | 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 | |||
| data element identifier | C142474 | Information associated with a data element that includes the origin of the data element, the date and time of entry, and 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. [From body and glossary of FDA Final Guidance eSource] | Data Element Identifier | |||
| data encryption standard (DES) | C142475 | 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. The standard specifies both enciphering and deciphering operations, which are based on a 64 bit binary number called a key. Unauthorized recipients of the cipher who know the algorithm but do not have the correct key cannot derive the original data algorithmically. 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. [from Federal Information Processing Standards (FIPS) Publication 46-2] | Data Encryption Standard | |||
| data entry | C142379 | Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. NOTE: Although data capture is often used synonymously, capture implies direct entry of original source data into an electronic record rather than transcription (entry) from paper source. Contrast with data acquisition, electronic data capture; direct entry. See data collection. | Data Entry | |||
| data integrity | C142476 | 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 | |||
| data integrity verification | C142477 | Process of manually supervised verification of data for internal consistency. | Data Integrity Verification | |||
| data interchange | C142478 | 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 | |||
| data item | C142479 | A named component of a data element. Usually the smallest component [ANSI]. See also data model, data element. | Data Item | |||
| data listing | C142483 | Set of observations organized by domain. | Data Listing | |||
| data management | C18086 | 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 | |||
| data management conventions | C142484 | 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 | |||
| data model | C142487 | 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 | |||
| data monitoring | C142488 | Process by which clinical data are examined for completeness, consistency, and accuracy. | Data Monitoring | |||
| data monitoring committee (DMC) | C142489 | DSMB;Data and Safety Monitoring Board | 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 | ||
| data origin | C16493 | 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 | |||
| data originator | C142490 | 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 | |||
| data quality | C142491 | 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 | |||
| data security | C142492 | 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 | |||
| data selection criteria | C142493 | 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 | |||
| data standards | C103180 | 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 | |||
| data storage | C142494 | 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 | |||
| data subject | C142495 | 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 | |||
| data transformations | C43582 | Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis. [ADaM] See also derived variable. | Data Transformation | |||
| data type | C42645 | 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 | |||
| data validation | C142500 | 1. Checking data for correctness and/or compliance with applicable standards, rules, and conventions. 2. Process used to determine if data are inaccurate, incomplete, or unreasonable. The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [1. FDA. 2. ISO] | Data Validation | |||
| database | C15426 | A collection of data or information, typically organized for ease and speed of search and retrieval. | Database | |||
| database lock | C142503 | 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 | |||
| dataset | C47824 | A collection of structured data in a single file. [CDISC, ODM, and SDS] Compare to analysis dataset, tabulation dataset. | Data Set | |||
| de-identification | C45970 | 1. The process of rendering data into a form that does not identify individuals and where identification is not likely to take place. A general term for a process of removing the association between a set of identifying data and the data subject. 2. Removal of elements connected with data which might aid in associating those data with an individual. Examples 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). [1. ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; 2. HIPAA: 45 CFR, 164.514] | Deidentification | |||
| de-identified information | C142507 | 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 | |||
| decision rule | C142504 | 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 | |||
| Declaration of Helsinki | C142505 | 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 | |||
| Define-XML | C142506 | 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] | Define.xml | |||
| demographic data | C142508 | 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 | |||
| dependent variable | C142509 | Outcomes that are measured in an experiment and that are expected to change as a result of an experimental manipulation of the independent variable(s). [Center for advancement of Clinical Research] | Dependent Variable | |||
| deployment | C142538 | 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 | |||
| derived variable | C142510 | New variable created as a function of existing variables and/or application of mathematical functions. See also variable, raw data. | Derived Variable | |||
| design configuration | C142442 | 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. [from ICH E9] | Clinical Trial Design Configuration | |||
| development plan | C142443 | 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 | |||
| DIBD (development international birth date) | C156648 | Analogous to the International Birth Date (IBD) for a PSUR, defined as the date of first marketing approval worldwide. [After ICH E2F - Development Safety Update Report] | Development International Birth Date | |||
| digital signature | C80447 | 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 | |||
| direct access | C142511 | 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 | |||
| direct entry | C142512 | 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 | |||
| direct identifier | C142513 | 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 | |||
| discontinuation | C142444 | The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. 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" has a history of synonymous use, but is now considered nonstandard. See also withdrawal and ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A. | Clinical Trial Discontinuation | |||
| discrepancy | C142473 | 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 | |||
| disease | C2991 | Any deviation from or interruption of the normal structure or function of a part, organ, or system of the body as manifested by characteristic symptoms and signs. [Dorland's Medical Dictionary] | Disease or Disorder | |||
| document (HL7) | C142571 | 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 | |||
| document root | C142751 | The element in an XML document that contains all other elements; the first element in the document. [SPL Glossary] | XML Document Root | |||
| document type definition (DTD) | C142515 | 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 | |||
| documentation | C19498 | 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 | |||
| domain | C62289 | 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 | |||
| domain name | C54076 | 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 | |||
| dosage | C94394 | 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 | |||
| dosage form | C42636 | 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 | |||
| dosage regimen | C142516 | The number of doses per given time period; the elapsed time between doses (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. [from Center for advancement of Clinical Research] | Dosage Regimen | |||
| dose | C25488 | Specified quantity of a medicine, to be taken at one time or at stated intervals. [ISO 11615:2012 Health Informatics] | Dose | |||
| dose strength | C142517 | The strength of a drug product, which indicates the amount of active ingredient in each dose. For liquids, it is the proportion of active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms] | dose strength | |||
| double-blind study | C15228 | A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows what treatment a subject is receiving. | Double Blind Study | |||
| double-dummy | C142518 | 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 | |||
| dropout | C142445 | 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 | |||
| drug | C1909 | Article other than food intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body. not a device or a component, part, or accessory of a device. [from FDA Glossary of Terms, CDER] See also medicinal product, active substance. | Pharmacologic Substance | |||
| drug development process | C142519 | The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies. | Drug Development Process | |||
| drug distribution | C79370 | 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 | |||
| drug product | C459 | 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] | Medication | |||
| dynamic HTML | C142520 | 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 | |||
| eCertified copy | C142525 | 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 | |||
| eClinical trial | C142526 | 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 [DRAFT Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. Synonyms: eClinical study, eClinical investigation. | Electronic Clinical Trial | |||
| eCRF (electronic case report form) | C142523 | 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 | |||
| eCRT (electronic case report tabulation) | C142524 | CRTs 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. Becoming obsolete, being replaced by SDTM. | Electronic Case Report Tabulation | |||
| EDC (electronic data capture) | C142527 | 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. See also data entry, direct data entry, data acquisition. | Electronic Data Capture | |||
| edit check | C142521 | 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 | |||
| EDR (electronic document room) | C156649 | 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 | |||
| effect | C18919 | 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 | ||
| effectiveness | C142522 | The desired measure of a drug's influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations. | Effectiveness | |||
| efficacy | C88183 | The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed. | Efficacy | |||
| EHR (electronic health record) | C142529 | 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 | |||
| electronic personal health record (ePHR) | C142530 | An electronic record for individuals to create, import, store, and use clinical information to support their own health. | Electronic Personal Health Record | |||
| electronic record | C142531 | 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 | |||
| electronic signature | C142533 | 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 | ||
| EMR (electronic medical record) | C45259 | 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 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). | Electronic Medical Record | |||
| end-point assessment medicinal product | C165826 | 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 | |||
| endemic disease | C171503 | 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 | |||
| endpoint | C25212 | A defined variable intended to reflect an outcome of interest that is statistically analyzed 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. [After BEST Resource] See also outcome, variable. | End Point | |||
| enrolled | C142715 | Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting inclusion criteria. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. [after Clinicaltrials.gov]. NOTE: A less common definition assigns enrolled status is the point of enrollment, Can be defined from the signing of an informed consent form. Other ways of defining enrollment or subject status can be specified in some protocols, e.g. non-interventional studies. See also informed consent. | Study Subject Enrolled | |||
| enrollment | C37948 | 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. See also enrolled. | Enrollment | |||
| enrollment (cumulative) | C142466 | Current enrollment including any subjects who were once enrolled and have ended participation. | Cumulative Enrollment | |||
| enrollment (current) | C142467 | Subjects actively continuing to participate in a clinical trial as of the current date. | Current Enrollment | |||
| epidemic | C171452 | 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 | |||
| epoch | C71738 | Interval of time in the planned conduct of a study. An epoch is associated with a purpose (e.g., screening, randomization, treatment, follow-up), which applies across all arms of a study. NOTE: Epoch is intended as a standardized term to replace: period, cycle, phase, stage. See also arm, visit. | Clinical Trial Epoch | |||
| ePRO | C137811 | 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 | |||
| equipoise | C142428 | 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 | |||
| equivalence trial | C142539 | 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 | |||
| eSource | C142536 | Source record that is electronic. See also source, electronic record. | Electronic Source Record | |||
| eSource data | C142534 | 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 | |||
| eSource document | C142535 | 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 | |||
| eSRF (electronic source report form) | C142537 | 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 | |||
| essential documents | C142540 | 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 | |||
| established name | C97104 | The official name of a drug substance. [Food, Drug, and Cosmetic Act] | Established Drug Name | |||
| ethics committee | C142541 | See institutional review board, independent ethics committee. | Ethics Committee | |||
| ethnicity | C16564 | Denotes social groups with a shared history, sense of identity, geography, and cultural roots. | Ethnic Group | |||
| European Medicines Agency (EMA) | C142543 | The regulatory agency for the EU. | European Medicines Agency | |||
| evaluable (for efficacy and safety) | C142546 | Pertains to data or subjects that meet statistical analysis Plan criteria for inclusion in efficacy/safety datasets. | Evaluable for Safety and Efficacy | |||
| event | C74589 | 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 | |||
| exclusion criteria | C25370 | List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. | Exclusion Criteria | |||
| excretion | C94618 | The act or process of eliminating waste products from the body. See also ADME. | Excretion | |||
| exploratory IND study | C142547 | 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 | |||
| exploratory study | C39538 | 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 | |||
| exposure | C17941 | 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 | |||
| exposure (individual) | C156623 | 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 | |||
| eXtensible markup language (XML) data element | C142548 | 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. [FDA - GL/IEEE] | Extensible Markup Language Data Element | |||
| extent of exposure | C156624 | 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 | |||
| extraction transformation load (ETL) | C142549 | 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 | |||
| feels | C142557 | 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 | |||
| field | C25507 | Locus on a data collection instrument (usually a CRF) for recording or displaying a data element. See data item. | Data Field | |||
| File Transfer Protocol (FTP) | C100047 | A standard protocol for exchanging files between computers on the internet. See also TCP/IP. | File Transfer Protocol | |||
| final report | C115575 | 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 | |||
| finding | C3367 | A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event. | Finding | |||
| first subject in - date, time (FSI - date, time) | C142558 | FPI - date, time;first patient in - 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 | ||
| first subject in - identity (FSI - identity) | C142559 | FPI - identity;first patient in - identity | The first subject enrolled. See also enrollment. | First Subject In Identity | ||
| first subject screened - date, time | C142560 | 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 | ||
| first subject screened - identity | C142561 | first patient screened - identity | The first subject who is so screened. | First Subject Screened Identity | ||
| first subject treated - date, time | C142562 | 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 | ||
| first subject treated - identity | C142563 | first patient treated - identity | The first subject who is so treated. | First Subject Treated Identity | ||
| first-in-humans study | C142564 | first-in-man study | The first Phase 1 study in which the test product is administered to human beings. | First-in-Human Study | ||
| Food and Drug Administration (FDA) | C17237 | The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals. | Food and Drug Administration | |||
| Form | C19464 | A collection of items and item groups for capturing and displaying clinical trial data. | Form | |||
| frequentist methods | C142565 | 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 | |||
| frozen | C142502 | 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 | |||
| functional roles (in a study) | C142438 | 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 | |||
| functions | C142468 | 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 | ||
| gender | C17357 | Subject self-identification re: masculine/feminine. [IOM] See also sex. | Gender | |||
| general observation class | C165827 | 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 | |||
| generalizability | C142429 | 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 | |||
| generic name | C97054 | The drug identifying name to which all branded (proprietary) names for that medicinal product are associated. | Generic Name | |||
| global assessment variable | C142566 | 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 | |||
| glossary | C18232 | A collection of specialized words or terms with their meanings. | Glossary | |||
| Good Clinical Practice (GCP) | C94236 | 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 | ||
| granularity | C142567 | 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 | |||
| group sequential design | C142568 | 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 | |||
| handwritten signature | C142569 | 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 | |||
| harmonized standard | C142542 | 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 | |||
| Health Level 7 (HL7) | C80485 | 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 | |||
| health-related quality of life (HRQoL) | C142570 | 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 | |||
| healthcare provider | C16666 | 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 | |||
| healthy volunteer | C49651 | 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. | Healthy Subject | |||
| HIE (Health Information Exchange) | C156650 | 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 | |||
| human subject | C70665 | 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 | ||
| Huriet Law | C142572 | France's regulations covering the initiation and conduct of clinical trials. | Huriet Law | |||
| hypertext | C142573 | 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 | |||
| HyperText Markup Language (HTML) | C142380 | A specification of the W3C that provides markup of documents for display in a web browser. [HL7] Contrast to XML. | Hypertext Markup Language | |||
| hypothesis to test | C142574 | 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 | |||
| immediately life-threatening disease or condition | C171511 | 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 | |||
| impartial witness | C142577 | 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 | |||
| inclusion criteria | C25532 | 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 | |||
| independent data monitoring committee (IDMC) | C142578 | 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 | |||
| independent ethics committee (IEC) | C142579 | 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. [ICH] See also institutional review board. | Independent Ethics Committee | |||
| indication | C41184 | 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 | |||
| indirect identifier | C142581 | 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 | ||
| informed consent | C16735 | 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 | |||
| ingredient | C51981 | Active and/or inactive material used in pharmaceutical product. [After ISO 11615:2017, 3.1.28] | Ingredient | |||
| inspection | C142448 | 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 | |||
| institution (medical) | C21541 | Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH] | Healthcare Facility | |||
| institutional review board (IRB) | C16741 | 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 trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. [ICH E6 1.31] | Institutional Review Board | ||
| instrument | C142631 | 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 | |||
| intended use | C54390 | 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 Intent of Use | |||
| intention-to-treat | C54398 | 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 | |||
| inter-rater reliability | C78688 | The property of scales yielding equivalent results when used by different raters on different occasions. [ICH E9] | Inter-rater Reliability | |||
| interaction (qualitative and quantitative) | C142732 | 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 | |||
| interim analysis schedule | C142583 | The time/information points at which interim analyses are planned. | Interim Analysis Schedule | |||
| interim analysis(es) | C142582 | Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete. [CONSORT statement] | Interim Analysis | |||
| interim clinical trial/study report | C115555 | A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH] | Interim Analysis Output | |||
| internal consistency | C78687 | Pertaining to data that do not include contradictions. | Internal Consistency | |||
| international birth date (IBD) | C142584 | The date of the first marketing authorization for a new product granted to any company in any country in the world. [ICH E2C(R2), Appendix A] | International Marketing Authorization Birth Date | |||
| international nonproprietary name (INN) | C142585 | A unique name that is globally recognized and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO] | International Nonproprietary Name | |||
| internet | C20342 | 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 | |||
| internet service provider (ISP) | C142586 | A company that provides access to the internet for individuals and organizations. | Internet Service Provider | |||
| interoperability | C142381 | 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 | |||
| intervention | C25218 | The drug, device, therapy, 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). See also test articles, devices, drug product, medicinal product, combination product, general observation class, finding, event. | Intervention or Procedure | |||
| interventional clinical trial | C98388 | A trial which intervenes with the inviolability of the trial subject for the purpose of the investigation. For example, the administration of an investigational medical product to the trial subject or use of some extra means of intervention (i.e., samples, tests, or questionnaires) that would not otherwise be used. [Clinical Trial Directive EC/20/2001 definitions] | Interventional Study | |||
| investigational product | C142587 | A pharmaceutical form of an active ingredient or placebo 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. NOTE: CDISC includes test articles in its definition of investigational products. Compare to authorised investigational medicinal product from EU-CTR (EU) No 536/2014. [ICH] | Investigational Product | |||
| investigator | C25936 | 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 | |||
| investigator's brochure | C79303 | 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 | |||
| investigator/institution | C142591 | 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 | |||
| item | C142431 | 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 | |||
| item (PRO) | C142629 | 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 | |||
| item definition | C142592 | Formal specification of the properties of an item or field of data in an eClinical trial. [CDISC ODM, CDISC CDASH] | Item Definition | |||
| item generation | C142630 | 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 | |||
| item group definition | C142593 | 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 | |||
| Janus conceptual model | C142594 | 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 | |||
| Janus study data repository | C142595 | 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 | |||
| label | C41203 | 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 | ||
| labeling (content of) | C54694 | 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 | |||
| laboratory (clinical) | C142432 | A laboratory providing analyses of samples collected in clinical care or research. | Clinical Laboratory | |||
| last subject in - date, time (LSI - date, time) | C142596 | LPI - date, time;last patient in - 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 | ||
| last subject in - identity (LSI - identity) | C142597 | LPI - identity;last patient in - identity | The last subject enrolled in a clinical trial. | Last Subject In Identity | ||
| last subject last visit - date, time (LSLV - date, time) | C142598 | 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 | ||
| last subject last visit - identity (LSLV - identity) | C142599 | LPC-dentity;LPO - identity;LSC - identity;LSO - identity;last subject complete - identity;last subject out - identity | The last subject to reach a planned or achieved milestone representing the completion of the trial. | Last Subject Last Visit Identity | ||
| legal authentication | C142514 | 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 | |||
| legally acceptable representative | C142600 | 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 | |||
| life-threatening adverse event/ experience | C84266 | 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 | |||
| longitudinal study | C15273 | 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 | |||
| low-interventional clinical trial | C142601 | 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 | |||
| manufacturer (device) | C156625 | 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 | |||
| manufacturer (drug) | C156626 | 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 | |||
| mapping | C142485 | In the context of representing or exchanging data, connecting an item or symbol to a code or concept. Compare to translation. | Data Mapping | |||
| marketing authorization | C156642 | 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 | ||
| marketing authorization holder | C88074 | Organization or person that is permitted to market a medicinal product in a jurisdiction. [After ISO 11615:2017, 3.1.41] | Marketing Authorization Holder | |||
| marketing authorization procedure | C142602 | 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 | |||
| marketing support trials | C142603 | 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 | |||
| markup | C63615 | 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 | |||
| master protocol | C165770 | A trial design that tests multiple drugs and/or multiple subpopulations in parallel under a single protocol, without the need to develop new protocols for every trial. 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 FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and 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.] See also umbrella protocol, basket protocol, platform protocol. | Master Protocol | |||
| matched-pair design | C142604 | 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 | |||
| mean | C53319 | The sum of the values of all observations or data points divided by the number of observations; an arithmetical average. | Mean | |||
| MedDRA (Medical Dictionary for Regulatory Activities) | C43820 | A global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others. | MedDRA | |||
| median | C28007 | 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 | |||
| medical countermeasure | C171514 | 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 | |||
| medical device | C16830 | Medical device means 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] | Medical Device | |||
| medical monitor | C51836 | A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial. | Medical Monitor | |||
| medical monitoring | C53607 | Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose in the context of medical care. NOTE: Medical monitoring refers to delivery of medical diagnosis and established treatment linked to a specific disease, and does not include monitoring of patient safety or well being in the context of tracking subject status during clinical trials. Such a medical purpose is a key in establishing that a given instrument, software program or measuring device is subject to regulations pertaining to a medical device. [After MHRA Guidance: Medical device stand-alone software including apps] See also medical device; DSMB, clinical trial, non-interventional trial. | Patient Monitoring | |||
| medication error | C156627 | 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 | |||
| medicinal product | C142605 | 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 | |||
| medicinal product classification | C156643 | 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 | |||
| medicinal product identifier | C142606 | 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 | |||
| medicinal product name | C142607 | 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] | Medicinal Product Name | |||
| Medicines and Healthcare products Regulatory agency (MHRA) | C142608 | The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. [MHRA] | Medicines And Healthcare Products Regulatory Agency | |||
| mega-trials | C142609 | large sample trial | Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects. | Mega-Trial | ||
| memorandum of understanding (MOU) | C142553 | 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 | |||
| message (HL7) | C142486 | 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 | |||
| meta-analysis | C17886 | 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. [from ICH E9 Glossary] | Meta-Analysis | |||
| metabolism | C19536 | The biochemical alteration of substances introduced into the body. | Metabolic Process | |||
| metadata | C52095 | Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields. | Metadata | |||
| migration | C142726 | 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 | |||
| minor | C156663 | 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 | |||
| missing data | C142610 | 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 | |||
| mode | C53320 | The most frequently occurring value in a data set. | Mode | |||
| model | C16866 | 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 | |||
| modem | C50072 | 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 | |||
| moiety | C103246 | 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 | |||
| monitor | C41201 | 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 | |||
| monitoring | C61256 | Act of overseeing, tracking, observing, or supervising something over a period of time in order to see how it develops, so that any necessary changes can be identified and made, whether performed by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring. | Monitoring | |||
| monitoring plan | C115753 | A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. NOTE: The term refers to the documented plan for site monitoring performed by the CRA(s). [After ICH E6(R2) Glossary, 1.64] | Clinical Trial Monitoring Plan | |||
| monitoring report | C142708 | 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 | |||
| monitoring visit | C142709 | 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 | |||
| morbidity rate | C16877 | A measure of the frequency of occurrence of a specific illness 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] | Morbidity | |||
| mortality rate | C16880 | A measure of the frequency of occurrence of death in a well defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] | Mortality | |||
| multicenter study | C142611 | See multicenter trial. | Multi-Institutional Clinical Study | |||
| multicenter trial | C16104 | 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. | Multi-Institutional Clinical Trial | |||
| mutual recognition procedure (MRP) | C156635 | 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 | |||
| n-of-1 study | C142614 | 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 | |||
| natural language | C142612 | 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 | |||
| NCI Enterprise Vocabulary Services (EVS) | C43515 | 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 | |||
| New Drug Application (NDA) | C72899 | An application to FDA for a license to market a new drug in the United States. | New Drug Application | |||
| new safety information | C142613 | With respect to a drug, information derived from a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; data derived from the post-market risk identification and analysis system (REMS); or other scientific data regarding: (a) 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 (b) 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 | |||
| NOEL (no observable effect level) | C156651 | The dose of an experimental drug given preclinically that does not produce an observable toxicity. | No Observable Effect Level | |||
| nomenclature | C48298 | Application of naming conventions. Compare to vocabulary, terminology. | Nomenclature | |||
| non-confirmatory result | C165828 | 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 | |||
| non-interventional study | C142615 | 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 | |||
| nonclinical study | C48678 | Biomedical studies not performed on human subjects. [ICH E6 (R2)] | Nonclinical Study | |||
| not approvable letter | C142554 | 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 | |||
| Notified Body (NB) | C142545 | 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 | |||
| null hypothesis | C142616 | 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 | |||
| Nuremberg Code | C142617 | Code of ethics, set forth in 1947, for conducting human medical research. | Nuremberg Code | |||
| objective | C142450 | The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective 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). Secondary objectives are goals of a trial that will provide further information on the use of the treatment. | Clinical Trial Objective | |||
| objective measurement | C142618 | A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment. See also outcome, patient-reported outcome; objective measures are observations (SDTM) and could be endpoints. Patient-reported outcomes are subjective measurements. | Objective Measurement | |||
| observation | C116555 | 1. an assessment of patient condition or analysis of data collected on an individual patient or group of patients. 2. (SDTM) a discrete piece of information collected during a study. NOTE: observations (meaning 1) are required by protocol (e.g., require evaluation of patient or data by investigator/staff). such planned observations are typically distinguished from anecdotal comments noted during a clinical trial (which qualify as observations under meaning 2). See also variable. Referring to an ad hoc comment as an observation is colloquial. [1. CONSORT statement. 2. SDTM] | Clinical Observation | |||
| observer assessment | C142619 | 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 | |||
| observer-reported outcome (ObsRO) | C142620 | 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 FDA-NIH BEST Resource] | Observer-reported Outcome | |||
| official protocol title | C132346 | 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 [WHO ICTRP]. The official protocol title should be sufficiently different from other official protocol titles to create brevity with specificity [NIH Protocol Template]. | Official Protocol Title | ||
| ontology | C21270 | 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 | |||
| open to enrollment | C142621 | 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 | |||
| open-label study | C49659 | 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 | |||
| operational model | C142622 | The set of CDISC data standards (including ODM and LAB) used to capture and archive data from clinical trials. | Operational Model | |||
| opinion (in relation to independent ethics committee) | C142580 | The judgment and/or the advice provided by an independent ethics committee. [ICH E6 Glossary] | Independent Ethics Committee Opinion | |||
| original data | C142623 | 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 | |||
| other serious (important medical events) | C82521 | 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 the determination of 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 | |||
| outcome | C20200 | 1. events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. (SDTM) The result of carrying out a mathematical or statistical procedure. NOTE: 1. such events and experiences are called clinical outcomes independently of whether they are part of the original question/protocol of the investigation. [1. Guyatt, G., Schunemann H., Dept. epidemiology & statistics, McMaster University-personal communication] See also variable; outcome can be a result of analysis; outcome is more general than endpoint in that it does not necessarily relate to a planned objective of the study.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. [BEST Resource] | Outcome | |||
| outcome (of adverse event) | C49489 | 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 | |||
| outcomes research | C15365 | 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 | |||
| outliers | C79083 | Values outside of an expected range. | Outlier | |||
| overdose | C50873 | 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 | |||
| p-value | C44185 | Study findings can also be assessed in terms of their statistical significance. The p-value represents the probability that the observed data (or a more extreme result) could have arisen by chance when the interventions did not differ. [CONSORT statement] | P-Value | |||
| packaging | C84731 | 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 | Packing | |||
| pairing | C142624 | 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 | ||
| pandemic | C171519 | 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 | |||
| parallel trial | C82639 | parallel design trial;parallel group trial | Subjects are randomized to one of two or more differing treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. | Parallel Study | ||
| parameter | C44175 | 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 | |||
| participant | C156779 | 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 | |||
| password aging | C142626 | 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 | |||
| patient | C16960 | 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 | |||
| patient file | C142627 | 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 | |||
| patient-reported outcome (PRO) | C95401 | 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 | |||
| per-protocol analysis set | C142635 | 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 | |||
| performance outcome (PerfO) | C142632 | 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. FDA-NIH BEST Resource] | Performance Outcome | |||
| performed activity | C70900 | Clinical trial events as they actually occurred (as compared with events planned in the protocol). | Performed Clinical Study Activity | |||
| period effect | C142633 | An effect occurring during a period of a trial in which subjects are observed and no treatment is administered. | Period Effect | |||
| permanent data | C142634 | 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 | |||
| permissible values | C41109 | Limited universe of options for data items. (e.g., drop-down menus, codelists, pick lists). | Permissible Value | |||
| personally identifiable information (PII) | C90492 | 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 | |||
| pharmaceutical product | C42639 | 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 | |||
| pharmacodynamics | C15720 | Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents. | Pharmacodynamics | |||
| pharmacoeconomics | C142636 | 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 | |||
| pharmacogenetic test | C68761 | 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 | |||
| pharmacogenetics | C16973 | Study of the way drugs interact with genetic makeup or the study of genetic response to a drug. | Pharmacogenetics | |||
| pharmacogenomic test | C68762 | 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 | |||
| pharmacogenomics | C20050 | 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 | |||
| pharmacokinetics | C15299 | Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products. | Pharmacokinetics | |||
| pharmacology | C16974 | Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms. | Pharmacology | |||
| pharmacovigilance | C142637 | Term used for adverse event monitoring and reporting. pharmacovigilance. Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. 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] | Pharmacovigilance | |||
| phase | C48281 | One in a set of successive stages in a progression or sequence such as 1. a step in the progression of a therapy from initial experimental use in humans to postmarket evaluation. 2. a stage in the conduct of a clinical trial. 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. For meaning 1, see Phase 0-5. For meaning 2, see epoch. | Trial Phase | |||
| phase 0 | C54721 | First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent. NOTE: FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, January 2006 classifies such studies as Phase 1. NOTE: A Phase 0 study might not include any drug delivery but may be an exploration of human material from a study (e.g., tissue samples or biomarker determinations). [Improving the Quality of Cancer Clinical Trials: Workshop summary-Proceedings of the National Cancer Policy Forum Workshop, improving the Quality of Cancer Clinical Trials (Washington, DC, Oct 2007)] | Phase 0 Trial | |||
| phase 1 | C15600 | The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. 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 FDA CDER handbook, ICH E8] | Phase I Trial | |||
| phase 2 | C15601 | Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [after FDA CDER handbook, ICH E8] | Phase II Trial | |||
| phase 2a | C49686 | Controlled clinical studies that occur after the completion of Phase 1 studies and the first set of exposure-response studies in patients, and before beginning Phase 2b (i.e., patient dose-ranging trial) and Phase 3 clinical efficacy-safety studies. [FDA draft Guidance for industry end of Phase 2a meetings, 9/08]. | Phase IIa Trial | |||
| phase 3 | C15602 | Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [after FDA CDER handbook, ICH E8] | Phase III Trial | |||
| phase 3b | C49689 | A subcategory of Phase 3 trials 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 IIIb Trial | |||
| phase 4 | C15603 | 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: These 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] | Phase IV Trial | |||
| phase 5 | C47865 | Postmarketing surveillance is sometimes referred to as Phase 5. See also outcomes research. | Phase V Trial | |||
| placebo | C753 | A pharmaceutical preparation that does not contain the investigational agent. in blinded studies, it is generally prepared to be physically indistinguishable from the preparation containing the investigational product. | Placebo | |||
| platform protocol | C165829 | A type of master protocol that tests multiple, targeted therapies for a single disease simultaneously. NOTE: Platform protocols often include an adaptive design that may eliminate or add treatments based on interim analysis. [After Saville BR, Berry SM. Efficiencies of platform clinical trials: A vision of the future. Clin Trials. 2016 Jun;13(3):358-66 and 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.] See also master protocol, adaptive design. | Platform Protocol | |||
| population | C17005 | 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 | |||
| postmarketing commitment (PMC) | C142639 | Studies and clinical trials that applicants have agreed to conduct, but that will generally not be considered as meeting statutory purposes (see postmarketing requirement) and so will not be required. | Postmarketing Commitment | |||
| postmarketing requirement (pMR) | C97025 | FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] | Post Marketing Requirement | |||
| postmarketing surveillance | C142640 | Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies. | Postmarketing Surveillance | |||
| pragmatic trial | C142641 | Term used to describe a clinical study designed to examine the benefits of a product under real world conditions. | Pragmatic Trial | |||
| pre-approval access | C71724 | 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 | |||
| pre-market approval application (PMA) | C70880 | An application to FDA for a license to market a new device in the United States. | Pre-market Approval Application | |||
| preamble | C142555 | 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. [from 21CFR10.40] | FDA Regulation Preamble | |||
| preclinical studies | C142642 | 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 | |||
| primary completion date | C142643 | 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 | |||
| primary objective | C85826 | 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. | Trial Primary Objective | |||
| primary outcome variable | C142644 | 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 | |||
| principal investigator | C19924 | 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 | |||
| privacy breach | C156637 | 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 | |||
| product dose | C95344 | 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 | |||
| PROMIS | C102988 | 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 | |||
| proprietary name | C71898 | brand name | A commercial name granted by a naming authority for use in marketing a drug/device product. [SPL] | Proprietary Name | ||
| prospective study | C142646 | Investigation in which a group of subjects is recruited and monitored, and from whom data are collected, in accordance with criteria described in the protocol. | Prospective Study | |||
| protected personal data (PPD) | C142647 | 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 | |||
| protocol | C142451 | 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. NOTE: Present usage can refer to any of three distinct entities: 1) the plan (i.e., content) of a protocol, 2) the protocol document, and 3) a series of tests or treatments (as in oncology). [ICH E6 Glossary] | Clinical Trial Protocol | ||
| protocol amendment(s) | C132347 | 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 | |||
| protocol approval (Sponsor) | C142648 | 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 | |||
| protocol deviation | C50996 | 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 | |||
| Protocol Identifying Number | C132299 | Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [PR Project; EudraCT] | Protocol Identifier | |||
| protocol referenced documents | C142650 | Protocol referenced documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [from ICH E6 1.44] See also protocol. | Protocol Referenced Documents | |||
| protocol violation | C142185 | 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 | |||
| proxy (as an origin of outcome measures) | C142651 | 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 | |||
| proxy respondent | C142652 | 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 | |||
| proxy-reported outcome | C142653 | 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 | |||
| pseudonymization | C142654 | 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 | |||
| psychometric reliability | C142655 | 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, 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 | ||
| psychometric validation | C142656 | 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 | ||
| psychometrics | C17034 | The science of assessing the measurement characteristics of scales that assess human psychological characteristics. | Psychometrics | |||
| public protocol title | C94105 | 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] | Study Protocol Document Version Public Title | ||
| qualitative variable | C142657 | 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 | |||
| quality assurance (QA) | C15381 | 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] | Quality Assurance | |||
| quality control (QC) | C15311 | 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] | Quality Control | |||
| quality of life (QoL) | C17047 | 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 | |||
| quantitative variable | C142658 | One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum. | Quantitative Variable | |||
| query | C142480 | 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 | |||
| query management | C142481 | 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 | |||
| query resolution | C142482 | The closure of a query usually based on information contained in a data clarification. | Data Item Query Resolution | |||
| questionnaire | C17048 | 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 | |||
| race | C17049 | 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 | |||
| radiopharmaceutical medicinal product | C142659 | 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 | |||
| random allocation | C142660 | 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 | |||
| random number table | C142661 | Table of numbers with no apparent pattern used in the selection of random samples for clinical trials. | Random Number Table | |||
| random sample | C142662 | 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 | |||
| randomization | C25196 | 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: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, 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 | |||
| raw data | C142663 | 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 | |||
| RCRIM | C142666 | Regulated Clinical Research and information Management, which is a Technical Committee within HL7 (an acronym pronounced "arcrim"). | Regulated Clinical Research and Information Management | |||
| Real-World Data (RWD) | C165830 | 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] See also Real-World Evidence (RWE) | Real-world Data | |||
| Real-World Evidence (RWE) | C165831 | 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] See also Real-World Data (RWD). | Real-world Evidence | |||
| reconstruction (of a study) | C142712 | 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 | |||
| recruitment (investigators) | C142590 | Process used by sponsors to identify, select, and arrange for investigators to serve in a clinical study. | Investigator Recruitment Process | |||
| recruitment (subjects) | C78343 | 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 | |||
| recruitment period | C142664 | Time period during which subjects are or are planned to be enrolled in a clinical trial | Recruitment Period | |||
| recruitment target | C142665 | 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 | |||
| Reference information Model (RIM) | C80496 | An information model used as the ultimate defining reference for all HL7 standards. [HL7] | Reference Information Model | |||
| reference member state (RMS) | C156641 | 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 | |||
| regenerative medicine | C93254 | 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 https://www.sciencedirect.com/topics/engineering/regenerative-medicine and http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation. | Regenerative Medicine | |||
| regenerative medicine advanced therapy (RMAT) designation | C165832 | 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 | |||
| regenerative medicine therapy (RMT) | C165833 | 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 https://www.sciencedirect.com/topics/engineering/regenerative-medicine and http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation. | Regenerative Medical Therapy | |||
| registry | C93453 | 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 | |||
| regulatory application | C70868 | Application made to a health authority to investigate, market, or license a new product or indication. | Regulatory Application | |||
| regulatory authorities | C88081 | 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 | ||
| remote clinical trial | C165834 | 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 (e.g., not physically present) visits via electronic communication. | Remote Clinical Trial | |||
| repeat rule | C142667 | Guide for repeating activities specified in protocol, including such features as the number of cycles and the criteria for stopping. | Repeat Activity Until Rule | |||
| replacement | C142738 | The act of enrolling a clinical trial subject to compensate for the withdrawal of another. | Trial Subject Replacement | |||
| rescue medications | C165835 | 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 | |||
| research hypothesis | C142668 | 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 | |||
| residual risk | C142669 | 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 | |||
| response option | C142670 | 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 | |||
| result synopsis | C115629 | The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information. | Clinical Study Report Synopsis | |||
| results posting (results submission) | C142671 | 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 | |||
| results posting date (results submission date) | C142672 | 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 | |||
| retrospective data capture | C142673 | 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 | |||
| retrospective study | C53312 | A type of study in which analyses are carried out, according to a protocol, at the present time that looks to the past to examine medical events or outcomes. Data that were previously collected or analyzed are subjected to analysis for a new and different purpose. [After Song JW, Chung KC. Observational studies: cohort and case-control studies. Plast Reconstr Surg. 2010 Dec;126(6):2234-42.] | Retrospective Study | |||
| RHIO (Regional Health Information Organization) | C156652 | 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 | |||
| risk | C142718 | 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 | |||
| risk based monitoring | C142674 | A systematic, prioritized, risk-based approach to monitoring clinical trials. [After ICH E6(R2), 5.18.3] | Risk Based Monitoring | |||
| role (CDISC classifier) | C142414 | 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 | |||
| route of administration (ROA) | C38114 | 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 | |||
| SAFE | C142675 | BioPharma(TM) Digital Identity and Signature Standard. | SAFE-Biopharma Standard | |||
| safety | C60828 | 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 | |||
| safety and tolerability | C142676 | 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 | |||
| sample size | C53190 | A subset of a larger population, selected for investigation to draw conclusions or make estimates about the larger population. | Sample Size | |||
| sample size adjustment | C142677 | An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. | Sample Size Adjustment | |||
| sample size calculation | C115467 | 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 | |||
| schedule of activities | C132349 | 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 | ||
| schedule of assessments | C142678 | 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 | |||
| screen failure | C49628 | Potential subject who did not meet one or more criteria required for participation in a trial. See also screening of subjects. | Trial Screen Failure | |||
| screen/screening (of substances) | C142721 | 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 | |||
| screening (of sites) | C142689 | Determining the suitability of an investigative site and personnel to participate in a clinical trial. | Site Screening | |||
| screening (of subjects) | C48262 | A process of active consideration of potential subjects for enrollment in a trial. See also screen failure. | Trial Screening | |||
| screening trials | C71485 | Trials conducted to detect persons with early, mild, and asymptomatic disease. | Screening Study | |||
| script | C96999 | A program or a sequence of instructions that are interpreted or carried out by another program or by a person. | Script | |||
| secondary objective | C85827 | See objective. | Trial Secondary Objective | |||
| secondary outcome variable | C142680 | 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 | |||
| secondary sponsor | C142679 | 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 | |||
| self-evident change | C142681 | 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 | |||
| semantic | C54194 | 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 | |||
| semantic interoperability | C142682 | The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308] | Semantic Interoperability | |||
| SEND (standard for the exchange of nonclinical data) | C156653 | 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 | |||
| sensitive data | C142683 | 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 | |||
| serious adverse drug reaction | C142685 | 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 | |||
| serious adverse event (SAE) | C41335 | 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 | |||
| serious adverse experience (SAE) | C142686 | Any experience that suggests a significant hazard, contra-indication, side effect or precaution. See also serious adverse event. | Serious Adverse Experience | |||
| serious breach | C156636 | 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 | |||
| serious risk | C142687 | Risk of a serious adverse drug experience. [505-1(b) of FD&C Act (21 USC. 355-1(b)] | Serious Risk | |||
| server | C48297 | 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 | |||
| severe | C70667 | 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 | |||
| sex | C28421 | Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender. | Sex | |||
| side effects | C2861 | 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. See also adverse reaction. | Side Effect | |||
| signal of a serious risk | C142688 | 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 | |||
| single-blind study | C28233 | 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 | ||
| single-entity product | C165836 | 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 | |||
| site investigator | C51873 | 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 | |||
| SNOMED (Systematized Nomenclature of Medicine) | C53489 | 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 | |||
| social circumstances | C20188 | 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 | |||
| software | C17146 | Computer programs, procedures, rules, and any associated documentation pertaining to the operation of a system. | Computer Program | |||
| software as a medical device (SaMD) | C165837 | 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 | |||
| software validation | C142690 | 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. | Software Validation | |||
| software verification | C91996 | 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 | |||
| source | C25683 | 1. The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. 2. Sometimes used as shorthand for source documents and/or source data. NOTE: Accuracy, suitability, and trustworthiness are not defining attributes of "source." 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. See also original data, certified copy. [After ICH E6, CSUICI] | Source | |||
| source data | C125442 | 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 | |||
| source data verification | C142752 | The process of ensuring that data that have been derived from source data accurately represent the source data. | Source Data Verification | |||
| source document verification (SDV) | C142693 | 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 | |||
| source documents | C142692 | 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 | |||
| special populations | C18101 | 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 | |||
| special purpose domain | C165838 | 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 | |||
| specified substance | C142694 | 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 | |||
| sponsor | C70793 | An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. NOTE: If there is also a secondary sponsor, the responsible entity would be considered the primary sponsor. A corporation or agency whose employees conduct the investigation is considered a sponsor and the employees are considered investigators. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor. | Clinical Study Sponsor | |||
| sponsor-investigator | C142695 | 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 | |||
| standard | C81893 | 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 | ||
| standard deviation | C53322 | Indicator of the relative variability of a variable around its mean; the square root of the variance. | Standard Deviation | |||
| standard of care | C94396 | A guideline for medical management and treatment. | Best Practice | |||
| standard operating procedures (SOPs) | C48443 | Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH] | Standard Operating Procedure | |||
| standard treatment | C142696 | 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 | |||
| Standards Development Organization (SDO) | C165839 | 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 | |||
| statistical analysis plan | C115761 | 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 | |||
| statistical distribution | C53206 | A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style] | Statistical Distribution | |||
| statistical method | C19044 | The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [ICH E9; from the Center for Advancement of Clinical Research] | Statistical Technique | |||
| statistical significance | C61040 | State that applies when a hypothesis is rejected. Whether or not a given result is significant depends on the significance level adopted. For example, one may say "significant at the 5% level." This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it. | Statistical Significance | |||
| stem | C142628 | The prompt, question, or instruction in a PRO item. See also response option, item. | Patient Reported Outcome Stem | |||
| stochastic | C142697 | Involving a random variable; involving chance or probability. | Stochastic | |||
| stopping rules | C142698 | 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 | |||
| stratification | C25689 | Grouping defined by important prognostic factors measured at baseline. [ICH E9] | Stratification | |||
| structured data | C142699 | Structured health record information is divided 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 Data | |||
| structured product label (SPL) | C142700 | 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 | |||
| study completion | C70756 | 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 | |||
| study completion date | C142702 | 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 | |||
| study coordinator | C51880 | See clinical research coordinator. | Study Coordinator | |||
| Study Data Standardization Plan (SDSP) | C165840 | 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 | |||
| study description | C142704 | Representation of key elements of study (e.g., control, blinding, gender, dose, indication, configuration). | Study Description | |||
| study design | C15320 | 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 | |||
| study design rationale | C142705 | Reason for choosing the particular study design. | Study Design Rationale | |||
| study design schematic | C93682 | Schematic diagram (not tabular) of study design, procedures, and stages. [example: ICH E3 annexes iiia and iiib] Compare to schedule of assessments. | Study Schematic | |||
| study initiation date (date of first enrollment) | C139171 | Date and/or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. Compare to study start date. [Modified from ICH E3] | Date of First Enrollment into Study | |||
| study monitoring | C142707 | The act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary] | Study Monitoring | |||
| study participant | C142710 | 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, human subject, data subject, clinical research subject, participant. | Study Participant | |||
| study population | C70833 | 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 | |||
| study publication date | C142711 | 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 | |||
| study report completion date | C142713 | 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 | |||
| study start | C142714 | The formal recognition of the beginning of a clinical trial that is referred to in the clinical study report. | Study Start | |||
| study start date | C69208 | The date of formal recognition of the beginning of a clinical trial that is referred to in the clinical study report. NOTE: For example, The date that enrollment to the protocol begins. See study initiation date. [ClinicalTrials.gov] | Study Start Date | |||
| study treatment | C41161 | See intervention. | Protocol Agent | |||
| study variable | C142192 | A term used in trial design to denote a variable to be captured on the CRF. See also variable. | Study Variable | |||
| sub-investigator | C54622 | 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). [ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator. | Subinvestigator | |||
| subject completion | C70735 | 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 | |||
| subject data event | C142717 | A subject visit or other encounter where subject data are collected, generated, or reviewed. [SDTM] | Subject Data Event | |||
| subject identification code | C70731 | 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 | |||
| subject monitoring | C156639 | 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 | |||
| subject trial contact | C142638 | Any activity, anticipated in the study protocol, involving a subject and pertaining to collection of data. See visit. | Planned Trial Subject Contact | |||
| subject-reported outcome (SRO) | C21089 | An outcome reported directly by a subject in a clinical trial. [Patrick, D.l., 2003] See also patient-reported outcome (PRO). | Patient Self-Report | |||
| submission model | C142496 | 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 | |||
| superiority trial | C142722 | 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 | |||
| supplier | C142459 | An organization that enters into a contract with the acquirer for the supply of a system, software product, or software service under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30] | Computer System or Software Supplier | |||
| supporting variables | C142723 | See variable. [FDA Drug Review Glossary] | Supporting Variable | |||
| surrogate endpoint | C68772 | 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, https://www.ncbi.nlm.nih.gov/books/NBK338448/] | Surrogate Endpoint | |||
| surrogate marker | C142724 | A measurement of a drug's biological activity that substitutes for a clinical endpoint such as death or pain relief. | Surrogate Marker | |||
| surrogate variable | C142725 | 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 | |||
| survey | C17176 | 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 | |||
| suspension (of a clinical trial) | C156631 | 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] | Clinical Trial Suspension | |||
| synopsis | C68836 | 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 | |||
| syntactic | C54277 | 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 | |||
| system | C25700 | People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI] | System | |||
| t-test | C53231 | A statistical test used to compare the means of two groups of test data. | t-Test | |||
| table of roles and responsibilities | C125429 | A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials. | Clinical Trial Roles and Responsibilities Matrix | |||
| tabulation dataset | C142727 | 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 | |||
| target enrollment | C49692 | The number of subjects in a class or group (including the total for the entire trial) intended to be enrolled in a trial to reach the planned sample size. Target enrollments are set so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by agreement, algorithm, or other specified process. | Planned Subject Number | |||
| target population | C142728 | 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 | |||
| technology provider | C142729 | 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 | ||
| temporary halt (of a clinical trial) | C156630 | 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] | Clinical Trial Temporary Halt | |||
| term | C45559 | 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 | |||
| termination (of subject) | C142719 | Now considered nonstandard. See discontinuation. | Subject Termination | |||
| termination (of trial) | C142739 | Premature discontinuation of a trial prior to plan. [EU Clinical Trial Directive] | Trial Termination | |||
| terminology | C142730 | 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 | |||
| therapeutic area | C101302 | A group of diseases which have common characteristics (such as pertaining to the same organ or organ group (e.g., cardiology, neurology, gastrointestinal diseases) or have similar pathophysiology (immunology, oncology) and often are belonging to the field of expertise of a specific medical specialty. NOTE: This term is sometimes used for an individual disease in an medical field of expertise. | Therapeutic Area | |||
| therapeutic index | C18223 | 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 | |||
| therapeutic intervention | C49236 | See intervention. | Therapeutic Procedure | |||
| Tmax | C70919 | The time after dosing when Cmax occurs. | Tmax | |||
| token | C67478 | Physical key that provides access to a secure electronic system or location. | Token | |||
| traceability (data) | C165841 | 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 | |||
| transcription | C142497 | 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 | |||
| transition rule | C82567 | 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 | |||
| translation | C80450 | Converting information from one natural language to another while preserving meaning. Compare to mapping. | Translation | |||
| translational research | C15862 | 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 | |||
| transmit | C142499 | 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 | |||
| treatment benefit | C142731 | 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 | |||
| treatment-emergent adverse event | C142733 | An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. [ICH E9] | Treatment-Emergent Adverse Event | |||
| trial design element | C142735 | 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 | |||
| Trial Design Model | C142736 | 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 | |||
| trial monitoring | C15789 | Oversight of quality of study conduct and statistical interim analysis. [ICH E9] | Clinical Trials, Monitoring | |||
| trial site | C85838 | 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 | |||
| trial statistician | C142737 | 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 | |||
| triple-blind study | C66959 | 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 | |||
| trustworthy (electronic records) | C142740 | 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 | |||
| type 1 (or type I) error | C45726 | false positive | Error made when a null hypothesis is rejected but is actually true. | False Positive | ||
| type 2 (or type II) error | C93283 | false negative | Error made when an alternative hypothesis is rejected when it is actually true. | False Negative | ||
| type 3 (or type III) error | C142741 | Some statisticians use this designation for an error made when calling the less effective treatment the more effective treatment. | Type 3 Error | |||
| type of comparison | C142576 | 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 | |||
| umbrella protocol | C165842 | A type of master protocol designed to evaluate multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and 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.] See also master protocol. | Umbrella Protocol | |||
| unblinding | C142742 | Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators. | Unblinding | |||
| unequal randomization | C142743 | See randomization. | Unequal Randomization | |||
| unexpected adverse drug reaction | C142744 | 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 | |||
| unexpected serious risk | C142745 | 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 | |||
| uniform resource locator (URl) | C42743 | Address of a web page, for example, appliedclinicaltrialsonline.com. | Uniform Resource Locator | |||
| use case | C81930 | 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 | |||
| use error (device) | C156628 | 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 | |||
| user site testing (UST) | C142746 | 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 | |||
| valid | C71756 | 1. Sound 2. Well grounded on principles of evidence. 3. able to withstand criticism or objection. [FDA Glossary of Computerized System and Software Development Terminology] | Valid | |||
| validation | C16237 | 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. | Validation | ||
| variable | C54166 | Any entity that varies; any attribute, phenomenon, or event that can have different qualitative or quantitative values. | Variable | |||
| variance | C48918 | 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 | |||
| verification | C45513 | 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 | |||
| verification of data | C142501 | 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 | |||
| visit | C39564 | A clinical encounter that encompasses planned and unplanned trial interventions, procedures, and assessments that may be performed on a subject. A visit has a start and an end, each described with a rule. [CDISC Trial Design Project] | Patient Visit | |||
| vocabulary | C92442 | Terms that function in general reference to concepts that apply over a variety of languages are words, and their totality is a vocabulary. See also controlled vocabulary, terminology. | Vocabulary | |||
| vulnerable subjects | C142747 | 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. [ICH E6] See also human subject, patient, human subject, data subject, clinical research subject, participant, study participant. | Vulnerable Subjects | |||
| Warning Letter | C142556 | 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 | |||
| washout period | C42872 | 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 | |||
| web browser | C142748 | A computer program that interprets HTML and other Internet languages and protocols and displays web pages on a computer monitor. | Web Browser | |||
| web page | C142749 | A single page on a website, such as a home page. | Web Page | |||
| web server | C142750 | A computer server that delivers HTML pages or files over the World Wide Web. See also server. | Web Server | |||
| website | C67518 | 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 | |||
| weighting | C48192 | An adjustment in a value based on scientific observations within the data. | Importance Weight | |||
| well-being (of the trial subjects) | C142720 | The physical and mental integrity of the subjects participating in a clinical trial. [ICH] | Subject Well-Being | |||
| withdrawal | C49634 | 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 while the subject permits continued access to his/her medical records or identifiable information. Note that according to FDA regulations, when a subject withdraws from a study, the data collected on the subject to the point of withdrawal remain part of the study database and may not be removed. See also discontinuation. | Withdrawal by Subject | |||
| within-subject differences | C67498 | In a crossover trial, variability in each subject is used to assess treatment differences. | Intra Subject Variability | |||
| World Wide Web | C20461 | All the resources and users on the Internet that are using HTTP protocols. Also called the web and www. | World Wide Web | |||
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