CDISC Glossary Controlled Terminology

CDISC Glossary Controlled Terminology, 2023-12-15
NCI attributes
C67497CDISC Glossary

Codelist Definitions

(CDISC Submission Value)
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C67497.CDISC GlossaryCDISC Glossary
(CDISC Glossary)
C67497CDISC GlossaryThe terminology of the Clinical Data Interchange Standards Consortium (CDISC) glossary.CDISC Glossary Terminology
510(k)C80442510(k). Premarket Notification (PMN) required for certain medical devices. See Device Notification
abbreviationC42610A 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
absorptionC71733The 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 approvalC156638fast track designationRegulatory 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]Accelerated Approval
acronymC93495A 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 abbreviationAcronym
action letterC142550An 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)C142528Enabling an eClinical trial system to capture data; usually used for EDC systems.Electronic Data Capture Activation
active ingredient doseC95337active substance doseThe amount of a single active substance administered in a single dose.Active Ingredient Dose
active ingredientC82533Any 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 substanceC202486Substance responsible for the activity of the medicine. NOTE: The protocol may define the active substance in terms of the Anatomical Therapeutic Chemical (ATC) code (level 3-5). [EMA Glossary of regulatory terms; EU Reg 536/2014] See also international nonproprietary name (INN), generic name.Active Substance
adaptive designC98704A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. [Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry, FDA] See also master protocol.Adaptive Design
adequate and well-controlled studiesC142382Studies 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 formC142383Pharmaceutical 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)C25409The act of introducing a substance into or onto the body. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also route of administration, administrable dosage form.Administration
admission criteriaC142384Basis 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)C142385adverse drug experienceAny 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)C41331adverse experience;side effectsAny 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 reactionC41332A 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)C156645A 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)C156646A 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 +C156622ALCOA PlusAcronym 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
ALCOAC156621Acronym 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
alertC142753To 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
algorithmC16275Step-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 errorC142387The 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
amendmentC41200A written description of a change(s) to, or formal clarification of, a document.Amendment
American National Standards Institute (ANSI)C142388Founded 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 datasetC142389An 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 setC142390A 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 variablesC142391Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. See also variable.Analysis Variable
anchorC142436Designation 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
anonymizationC142392The 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 eventC156629Other 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
appletC142393A small application, typically downloaded from a server.Applet
applicable regulatory requirement(s)C142394Any law(s) or regulation(s) addressing the conduct of clinical trials of investigational products. [ICH E6(R2) Glossary, 1.4]Applicable Regulatory Requirement
approvable letterC142551An 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)C70800The 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 letterC70799An 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)C15538A 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
artificial intelligence (AI)C16309A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017)] See also machine learning, deep learning, natural language processing, synthetic data.Artificial Intelligence
assessmentC25217The interpretation or evaluation of an obtained value by using a test, tool, instrument, or expert judgement of the status of a study subject. [After BEST Resource] See also variable, outcome, endpoint.Assessment
attributableC25358A 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)C62618In data modeling, refers to specific items of data that can be collected for a class.Computer Programming Object Attribute
audit certificateC115469Document 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 reportC142395A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary]Audit Report
audit trailC142396A 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
auditC45269A 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
authorised auxiliary medicinal productC156618A 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 productC156617A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [After EU CTR (EU) No 536/2014] See also investigational medicinal product.Authorized Investigational Medicinal Product
authorizationC41192The 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 productC156473A 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)C142397The 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 materialC142649Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features.Protocol Background Material
background treatmentC165822Medicinal 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 studyC142398Trial in which a particular type of subject is equally represented in each study group.Balanced Study
bandwidthC142399An 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 assessmentC142400Assessment of subjects as they enter a trial and before they receive any treatment.Baseline Assessment
baseline characteristicsC142401Demographic, 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 imbalanceC142402A 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 trial designC202580A type of trial design under a master protocol designed to test a single investigational drug or drug combination in different populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol.Basket Trial Design
Bayesian approachesC142403Approaches 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 statisticsC142404Statistical 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 errorC142405Probability 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
biasC28232Bias 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 assaysC16341Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids.Bioassay
bioavailabilityC70913Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.Bioavailability
bioequivalenceC71763Scientific 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
biological productC307A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition. Such products may include virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product. NOTE: Biological products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Biological products are generally large, complex molecules and are often more difficult to characterize than small molecule drugs. [After 21 CFR 600.3; After FDA Biological Product Definitions] See also vaccine, cell therapy, gene therapy, pharmaceutical product, drug product, medicinal product.Biological Agent
Biologics licensing application (BLA)C71778Biologics licensing application (BLA). an application to FDA for a license to market a new biologic product in the United states.Biologics License Application
biomarkerC16342biological markerA 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,]Biomarker
biometric signatureC142406A 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
biosimilarC156644A 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
biostatisticsC16347Branch of statistics applied to the analysis of biological phenomena.Biostatistics
blind reviewC142407Checking and assessing data prior to breaking the blind, for the purpose of finalizing the planned analysis. [Modified ICH E9]Blind Review
blinded (masked) medicationsC142408Products 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 studyC70840A 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
blindingC49068A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. [After Abhaya Indrayan, Martin P. Holt. Concise Encyclopedia of Biostatistics for Medical Professionals. Chapman & Hall; November 17, 2016] See also double-blind study, single-blind study, triple-blind study. Contrast with open-label and/or unblinded study, masking.Blinded
blood drawC28221The collection of blood from a vein, most commonly via needle venipuncture. (NCI)Phlebotomy
branchC142701Point within a study design where there is an allocation of subject subsets to particular procedures or treatment groups.Study Branch
browserC80012Computer program that runs on the user's desktop computer and is used to navigate the World Wide Web. See also web browser.HTML Browser
cacheC63626Storage 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 effectC142409Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication's known biological activity.Carry-Over Effect
case historyC142588An 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)C40988case record formA 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)C142411In a paper submission, listings of data that may be organized by domain (type of data) or by subject. See also eCRT.Case Report Tabulation
case-control studyC15197Retrospective study in which individuals with an outcome (cases) are compared with those who do not have the outcome (controls). The outcome variable (disease, event, experience, biomarker) is chosen first, and the exposure (e.g., treatment) is evaluated in cases vs controls to see whether there is an association between exposure and outcome. [After AMA Manual of Style] See also outcome, observational study, exposure.Case-Control Study
categorical dataC142412Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.Categorical Data
causality assessmentC142413An 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 LibraryC142415A global, accessible, electronic library, which, through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. NOTE: Formerly known as CDISC SHARE. [CDISC]CDISC Library
CDISC standardsC142416A 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]. See also standard, data standards, Study Data Standardization Plan, and Standards Development Organization.CDISC Standard
cell therapyC70601The prevention or treatment of human disease by the administration of cells that have been selected, multiplied, and pharmacologically treated or altered outside the body (ex vivo), or methods (pharmacological as well as nonpharmacological) to modify the function of intrinsic cells of the body for therapeutic purposes (in vivo). NOTE: Cell therapies can be classified based on therapeutic indication, cell type, source of cells, and underlying technology, among others, in medical and regulatory contexts. [After; After Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007.] See also regenerative medicine therapy, regenerative medicine advanced therapy, gene therapy, biological product.Cellular Therapy
certified copyC142417A 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)C142418Persons 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 agentC158128A 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)C156647CHI 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
classC41106A 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 databaseC142419A 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 fileC142420When all data cleaning is completed and database is ready for quality review and unblinding.Clean File
clientC142421A 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 benefitC142422A 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 clarificationC142423A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.). See also self-evident change.Clinical Clarification
clinical dataC15783Data 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. []Clinical Data
clinical development planC142424A 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 architectureC142426Specification for the structure and semantics of "clinical documents" for the purpose of exchange. [HL7; SPL]Clinical Document Architecture
clinical documentC142425A 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 efficacyC39547Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans. [SQA]Treatment Efficacy
clinical encounterC142427Contact 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)C70755An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).Study on Hold
clinical investigationC142430Any 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) qualificationC142552A 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 outcome assessment (COA)C142378Any 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 pharmacologyC16975Science 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 research and developmentC142435The 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)C25465Person 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)C51811clinical coordinator;research coordinator;study coordinator;trial coordinatorStudy site staff member who executes, manages, and coordinates research protocols in the clinic setting including screening, enrollment, monitoring of patient candidates/participants, and administration of informed consent. Other duties may be included depending on the study site.Clinical Coordinator
clinical research subjectC70668A person who is enrolled into a clinical study or trial. See also study, trial, and study population.Clinical Study Subject
clinical significanceC82562Change 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 data elementC142437A 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 study reportC142439A 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 studyC15206A 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. [] See also clinical trial.Clinical Study
clinical trial authorizationC142440Authorization 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 dataC142441Data collected in the course of a clinical trial. See also clinical trial information.Clinical Trial Data
clinical trial exemption (CTX)C142446A 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 informationC142447Data 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 materialsC142449Complete set of supplies provided to an investigator by the trial sponsor.Clinical Trial Material
clinical trial registryC142452A 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;, 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 registryC156620A web-based publicly accessible platform for providing structured summary results information about clinical trials. See also clinical trial registry.Clinical Trial Results Registry
clinical trialC71104Interventional Clinical Trial;Interventional StudyA research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT).Clinical Trial
clinician-reported outcome (ClinRO)C142453A 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
co-packaged productC165824Two 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
codelistC142454Finite list of codes and their meanings that represent the only allowed values for a data item. A codelist is one type of controlled vocabulary. See also controlled vocabulary.Codelist
codingC80216In clinical trials, the process of assigning data to categories for analysis. NOTE: Adverse events, for example, may be coded using MedDRA.Encode
cognitive debriefingC142455A 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 studyC15208Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study, cohort.Cohort Study
cohortC61512A 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
combination productC54696A 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)C142456Any 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)C19984A 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 DocumentC142575A 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 studyC142457One in which the investigative drug is compared against another product, either active drug or placebo.Comparative Study
comparator (product)C142458An 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
compendial nameC202465A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. NOTE: Used for all drugs within the US. [After USP Nomenclature Guidelines (last revision on March 30, 2020)] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name.Compendial Name
Competent Authority (CA)C142544The 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)C142734Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. [Modified ICH E6 Glossary]Trial Compliance
computer applicationC42608application softwareSoftware designed to fill specific needs of a user; for example, software for navigation, project management, or process control.Computer Application
concept of interestC142433In 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
conceptC45728Discrete 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
concerned member state (CMS)C156640A 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] See also Mutual Recognition Procedure (MRP) and Reference Member State (RMS).Concerned Member State
confidence interval (CI)C53324A 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
confidentialityC16466Prevention of disclosure to other than authorized individuals of a sponsor's proprietary information or of a subject's identity. [ICH E6 Glossary]Confidentiality
confirmatory trialC142460Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result, pragmatic trial. Compare to exploratory trial.Confirmatory Trial
conformity assessmentC142461The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body (NB).Conformity Assessment
consent formC16468informed consent formDocument used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. it is designed to begin the informed consent process, which consists of conversations between the subject and the research team. if the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. Informed consent is sometimes administered electronically, i.e., eICF. See also informed consent.Consent Form
construct validation (COA)C156633construct validation (re COA)Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment (COA) conform to a priori hypotheses concerning logical relationships that should exist with other measures or characteristics of patients and patient groups. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource,] See also validation.Clinical Outcome Assessment Construct Validation
consumer safety officer (CSO)C142462FDA official who coordinates the review process of various applications.Consumer Safety Officer
content validation (COA)C156632content validation (re COA)Establishing from qualitative research the extent to which the clinical outcome assessment (COA) instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource,] See also validation.Clinical Outcome Assessment Content Validation
content validityC78690The 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 useC142434In 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 contactC142463Planned response to an anticipated but conditional event in a clinical trial. [CDISC Trial Design Project]Contingent Subject Trial Contact
contract research organization (CRO)C54148A 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
contractC115464A 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
control groupC28143The 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 recordsC142464To prepare and maintain case histories and other records for regulated clinical investigations or other regulated research. NOTE: Control is often used as a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare, maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2. CSUCT] See also record.Control of Electronic Records
controlC142703A comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature, synthetic data)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol), synthetic data.Study Control
controlled studyC28279A 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 vocabularyC48697controlled terminologyA 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 committeeC142465A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. [ICH E6]Coordinating Committee
coordinating investigatorC51818An 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
correlationC48834The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson's correlation or spearman's Rho. NOTE: Correlation does not necessarily mean causation. [After Hyperstat Online Glossary; CDISC ADaM]Correlation
covariate (prognostic)C142645Factor or condition that influences outcome of a trial. [ADaM]Prognostic Covariate
CRF (paper)C142625Case 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 dataC142410Subset of clinical trial data that are entered into fields on a case report form.Case Report Form Data
criterion validation (COA)C156634criterion validation (re COA)Establishing the extent to which the scores of a clinical outcome assessment instrument are related to a known gold standard measure of the same concept. For most COAs clinical outcome assessments (COAs), criterion validity cannot be measured because there is no gold standard. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource,] See also validation.Clinical Outcome Assessment Criterion Validation
cross-labeled productC165825An 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
cross-sectional studyC53310A study that measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period. [After British Medical Journal, Epidemiology for the uninitiated] See also observational study.Cross-Sectional Study
crossover trialC82637A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [After ICH E9]Crossover Study
CTCAE (Common Terminology Criterion for Adverse Events)C49704Standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. NOTE: CTCAE is often used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. [After NCI]Common Terminology Criteria for Adverse Events
CUI (common unique identifier)C70818A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.Concept Unique Identifier
curriculum vitae (CV)C54631Document that outlines a person's educational and professional history.Curriculum Vitae
data acquisitionC142469Capture 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 captureC142470The process of collecting and recording measures and assessments for a specific purpose. NOTE: Data are said to be captured when they are extracted as permanent records for use in a new context or created as a source document in that context. An example would be data that are manually copied or otherwise extracted from an EHR that are then transferred into a clinical trial database to be used for a clinical trial. [After Working with Data, Australian National Data Service, Accessed 4 Sept 2020; AFter FDA Guidance on Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry, July 2018] See also data entry, EDC (electronic data capture).Data Capture
data clarification formC115521A form used to query an investigator and collect feedback to resolve questions regarding data.Data Clarification Form
data clarificationC142471Answer 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 collection instrumentsC142472Documents or tools which are used to collect, record or transcribe information on substantially identical items from a group of respondents. NOTE: Instruments can be either electronic or paper based tests, questionnaires, inventories, interview schedules or guides, rating scales, and survey plans or any other forms. [After 45 CFR 63.32]Data Collection Instrument
data collectionC103159In 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 element identifierC142474An identifier that may include information such as the origin of the data element, the date and time of entry, or the identification number of the study subject to whom the data element applies. NOTE: Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. [After body and glossary of FDA Final Guidance eSource]Data Element Identifier
data elementC41002Smallest 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 encryption standard (DES)C142475A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. NOTE: Data that are considered sensitive by the responsible authority or data that represent a high value should be cryptographically protected if vulnerable to unauthorized disclosure or undetected modification during transmission or while in storage. [After Federal Information Processing Standards (FIPS) Publication 46-2]Data Encryption Standard
data entryC142379Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. Contrast with data acquisition, electronic data capture, direct entry. See also data collection, data capture.Data Entry
data integrity verificationC142477Process of manually supervised verification of data for internal consistency.Data Integrity Verification
data integrityC142476A 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 interchangeC142478Transfer 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 itemC142479A named component of a data element. Usually the smallest component [ANSI]. See also data model, data element.Data Item
data listingC142483Set of observations organized by domain.Data Listing
data management conventionsC142484Procedures 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 managementC18086Tasks 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 modelC142487Unambiguous, 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 committee (DMC)C142489Data and Safety Monitoring Board;DSMBGroup 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 monitoringC142488Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle. NOTE: Monitoring is undertaken by qualified study personnel following a specific process and auditable methods. See also ALCOA+Data Monitoring
data originC16493Source 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 originatorC142490Metadata 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 qualityC142491A 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 securityC142492Degree 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 criteriaC142493The 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 sharingC191275Providing clinical trial data or access to data and final results to key stakeholders with the goal of increasing scientific knowledge and ultimately better therapies for patients. NOTE: guiding principles for data sharing: (1) maximize the benefits of clinical trials while minimizing the risks or harm of sharing clinical trial data, (2) respect individual participants whose data are shared, (3) increase public trust in clinical trials and the sharing of trial data, and (4) conduct the sharing of clinical trial data in a fair manner. [After National Academies of Sciences, Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press, 2015, accessed 2022-09-07]Clinical Data Sharing
data standardsC103180Defined 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 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 storageC142494To 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 subjectC142495In 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 transformationsC43582Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis. [ADaM] See also derived variable.Data Transformation
data typeC42645Data 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 validationC142500Process used to determine whether data are accurate, authentic, complete, and/or compliant with applicable standards, rules, and conventions. NOTE: The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [After FDA.; ISO] See also data integrity, validation.Data Validation
dataC25474Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA]Data
database lockC142503Action 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
databaseC15426A collection of data or information, typically organized for ease and speed of search and retrieval.Database
datasetC47824A collection of structured data in a single file. [CDISC] Compare to analysis dataset, tabulation dataset.Data Set
date of first enrollmentC139171Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] Compare to study start date.Date of First Enrollment into Study
de-identificationC45970The process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. NOTE: A general term for a process of removing the association between a set of identifying data and the data subject. Examples of potentially identifying data include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [After ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; HIPAA: 45 CFR, 164.514] See also anonymization.Deidentification
de-identified informationC142507Records 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
decentralized clinical trial (DCT)C176257A trial in which data capture, administration of medication, and possibly other procedures are done at the subject's location, e.g., at home or by telemedicine, mobile technology, and local HCPs (like family physicians, general practitioners). NOTE: The procedures (entry of data, medical tests, clinical evaluations, objective measures, observations) for capturing safety and efficacy measurements and observations may be done in-person by a traveling clinician or nurse so DCTs are not necessarily virtual. The responsibility for preparation, maintenance and retention of source records may be allocated to a centralized investigator or sponsor investigator. [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also remote clinical trial, virtual, visit.Decentralized Clinical Trial
decision ruleC142504Succinct 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 HelsinkiC142505A 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
deep learningC176258A subset of machine learning that is part of the broader family of machine learning methodologies based on artificial neural networks. A deep neural network has multiple layers between input and output layers to progressively extract higher level features from the raw input. [After DeepAI Machine Learning Glossary and Terms] See also machine learning, artificial intelligence (AI).Deep Learning
Define-XMLC142506A 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] See also eXtensible markup language (XML) data element, XML (eXtensible Markup Language).Define.xml
demographic dataC142508Characteristics 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 variableC142509A variable that is expected to change as a result of an experiment. Dependent variables are influenced by independent variables. [After AMA Manual of Style] See also independent variable.Dependent Variable
deploymentC142538Readying 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 variableC142510New variable created as a function of existing variables and/or application of mathematical functions. See also variable, raw data.Derived Variable
design configurationC142442Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [After ICH E9]Clinical Trial Design Configuration
development planC142443An 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
diagnosisC15220A process to identify the disease or condition that explains the symptoms and signs occurring in a patient. NOTE: The information required for diagnosis is collected from a history and physical examination of the patient and preferably confirmed by one or more diagnostic procedures such as laboratory tests, radiologic studies and other technical investigations. [After "Making a diagnosis", John P. Langlois, Chapter 10 in Fundamentals of clinical practice (2002). Mark B. Mengel, Warren Lee Holleman, Scott A. Fields. 2nd edition.] See also treatment, intervention, disease, sign, symptom.Diagnosis
DIBD (development international birth date)C156648The sponsor's first authorization to conduct a clinical trial in any country worldwide. NOTE: Used to start the annual period for the Development Safety Update Report (DSUR). [After CIOMS VII; ICH E2F]Development International Birth Date
digital signatureC80447An 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 accessC142511Permission 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 entryC142512Recording 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 identifierC142513A 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
discontinuationC142444The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] See also withdrawal.Study Subject Discontinuation
discrepancyC142473The 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
diseaseC2991Any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the affected person. NOTE: The term is often used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function. [After NCI Thesaurus] See also diagnosis.Disease or Disorder
document (HL7)C142571An 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 rootC142751The 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)C142515XML 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
documentationC19498All 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 nameC54076The way a particular web server is identified on the internet. For example, 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
domainC62289A 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,] See also general observation class.Domain
dosage formC42636dose form;pharmaceutical formPhysical 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 regimenC142516The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style]Dosage Regimen
dosageC94394The 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
dose strengthC142517The strength of a drug product, which indicates the amount of each active ingredient in a single dose. For liquids, it is the proportion of each active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms]dose strength
doseC25488Specified quantity of a medicine, to be taken at one time or at stated intervals. [ISO 11615:2012 Health Informatics]Dose
dose-escalation trialC90475A study in which the dosage of the test article is increased until the desired physiological effect or toxicity is seen. (CDISC; After ICH E4)Titration Study
double-blind studyC15228A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows the treatment a subject is receiving. [After FDA Glossary of Terms]Double Blind Study
double-dummyC142518A 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
dropoutC142445A 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 development processC142519The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.Drug Development Process
drug distributionC79370In 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 productC459A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21CFR210.3] See also medicinal product, dosage form.Medication
drugC1909An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)]. See also medicinal product, active substance.Pharmacologic Substance
dynamic HTMLC142520Collective 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
early termination of trialC184387premature termination of trialThe premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with. [REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC; ICH E6] See also termination (of a clinical trial).Early Termination of Trial
eCertified copyC142525A 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 trialC142526eClinical investigation;eClinical studyClinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for conduct, management, analysis, and reporting of the trial. NOTE: FDA has recently drawn a distinction between studies and trials. Both words refer to systematic efforts to obtain evidence relevant to regulatory authorities, but, depending on regulatory context and particularly in the case of postmarketing commitments, a study might not be the appropriate word for a clinical trial (prospective, controlled, randomized), but should be reserved instead for surveillance, structured gathering of information, epidemiological studies, or even animal studies [Guidance for industry Postmarketing studies and Clinical Trials-implementation of section 505(o) of the Federal Food, Drug, and Cosmetic act]. See also clinical study, clinical trial.Electronic Clinical Trial
eCRF (electronic case report form)C142523An 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)C142524Case report tabulation (CRT) provided in electronic format for eSubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. SDTM is the preferred format.Electronic Case Report Tabulation
EDC (electronic data capture)C142527The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] See also data entry, direct data entry, data acquisition, data capture.Electronic Data Capture
edit checkC142521An 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)C156649The 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
effectC18919treatment effectAn 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
effectivenessC142522A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy.Effectiveness
efficacyC88183A measure of intended effect on the disease or condition based on adequate and well-controlled clinical trials. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also effectiveness.Efficacy
EHR (electronic health record)C142529An 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)C142530An electronic record for individuals to create, import, store, and use clinical information to support their own health.Electronic Personal Health Record
electronic recordC142531Any 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 signatureC142533eSignatureA 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
eligibility criteriaC16112Requirements that must be met for a person to be included in a study, which help make sure that the results of the study are caused by the intervention being tested and not by other factors. NOTE: Eligibility Criteria, including inclusion and exclusion criteria, should enable constitution of the targeted cohorts in the clinical study. [After NCI's Dictionary of Cancer Terms]Clinical Trial Eligibility Criteria
emergency use authorizationC96966EUAApproval by FDA for the emergency use of certain unapproved medical products or an unapproved use of an approved medical product for certain emergency circumstances, when applied for under a declared health emergency. These medical products may be referred to as medical countermeasures (MCMs) and may include drugs, biologics, and devices. [After Emergency Use Authorization of Medical Products and Related Authorities. FDA Guidance for Industry and Other Stakeholders. January 2017.] See also pre-approval access.Emergency Use Authorization
EMR (electronic medical record)C45259An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs (or EHRs) may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11). [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018]Electronic Medical Record
end-point assessment medicinal productC165826Medicinal 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 diseaseC171503The 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
endpointC25212A defined variable intended to reflect an outcome of interest to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. Primary endpoints are usually statistically analyzed. [After BEST Resource] See also outcome, variable, surrogate endpoint.End Point
enrolledC142715Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. A less common definition confers enrolled status at the signing of an informed consent form, e.g., See also informed consent, enrollment.Study Subject Enrolled
enrollment (cumulative)C142466Current enrollment including any subjects who were once enrolled and have ended participation.Cumulative Enrollment
enrollment (current)C142467Subjects actively continuing to participate in a clinical trial as of the current date.Current Enrollment
enrollmentC37948The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. [After Glossary Of Terms On Clinical Trials For Patient Engagement Advisory Committee Meeting] See also enrolled.Enrollment
epidemicC171452The 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
epochC71738Planned interval of time in the conduct of a study wherein an activity is specified and consistent, e.g., specific treatment dose or study activity such as Screening. NOTE: A CDISC variable used in the SDTM model to indicate a time period defined in the protocol with a study-specific purpose. See also arm, visit, phase (within a study).Clinical Trial Epoch
ePROC137811Patient 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
equipoiseC142428A 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 trialC142539A 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 dataC142534Source 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 documentC142535Electronic 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
eSourceC142536Source record that is electronic. See also source, electronic record.Electronic Source Record
eSRF (electronic source report form)C142537The 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 documentsC142540Documents 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 nameC97104The official name of a drug or pharmaceutical product, relevant in US regulations. [US FDA, 21 CFR 299.4] See also proprietary name, generic name, international nonproprietary name (INN), medicinal product name, compendial name.Established Drug Name
estimandC188813A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarizes at a population level what the outcomes would be in the same patients under different treatment conditions being compared. NOTE: The four characteristics of an estimand include the definition of the target study population, statement of the endpoint of interest, intercurrent event details, and the population level summary of the variable of interest. (ICH E9 R1 Addendum; After Estimand Framework: What it is and Why You Need it. Applied Clinical Trials. February 27, 2020]Estimand
ethics committeeC142541Group convened to protect research subjects. NOTE: Such bodies, depending on the country or region, are abbreviated as: CCI, CCPPRB, CHR, CPPHS, CRB, EAB, HEX, HSRC, LREC, MREC, NIRB, NRB, and REB. See also institutional review board, independent ethics committee.Ethics Committee
ethnicityC16564Denotes social groups with a shared history, sense of identity, geography, and cultural roots.Ethnic Group
European Medicines Agency (EMA)C142543The regulatory agency for the EU.European Medicines Agency
evaluable (for efficacy and safety)C142546Pertains to data or subjects that meet Statistical Analysis Plan criteria for inclusion in efficacy/safety datasets.Evaluable for Safety and Efficacy
eventC74589Planned 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,] See also general observation class, intervention, finding.Protocol Event
exclusion criteriaC25370List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study.Exclusion Criteria
excretionC94618The act or process of eliminating waste products from the body. See also ADME.Excretion
expansion cohort trialC191276A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022]Expansion Cohort Trial
experimental interventionC41161Study Treatment;Target Product;Test ArticleThe drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). NOTE: This does not include comparators or placebos. [After;] See also test articles, devices, drug product, combination product, treatment, diagnosis, investigational medicinal product.Protocol Agent
experimental unitC93388A physical entity which is the primary interest in a specific research objective. NOTE: Depending on the research objectives, a single study may have multiple levels of experimental units. Commonly the individual study subject (animal, person or product) is the experimental unit. (BRIDG v5.3)Experimental Unit
exploratory IND studyC142547A 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 studyC39538Phase 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 (individual)C156623The 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
exposureC17941Contact 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
eXtensible markup language (XML) data elementC142548For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019] See also XML (eXtensible Markup Language), Define-XML.Extensible Markup Language Data Element
extent of exposureC156624A 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)C142549A 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
feelsC142557A 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
fieldC25507Locus on a data collection instrument (usually a CRF) for recording or displaying a data element. See data item.Data Field
File Transfer Protocol (FTP)C100047A standard protocol for exchanging files between computers on the internet. See also TCP/IP.File Transfer Protocol
final reportC115575A 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
findingC3367A 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)C142558first patient in - date, time;FPI - date, timeThe 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)C142559first patient in - identity;FPI - identityThe first subject enrolled. See also enrollment.First Subject In Identity
first subject screened - date, timeC142560first patient screened - date, timeThe 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 - identityC142561first patient screened - identityThe first subject who is so screened.First Subject Screened Identity
first subject treated - date, timeC142562first patient treated - date, timeThe 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 - identityC142563first patient treated - identityThe first subject who is so treated.First Subject Treated Identity
first-in-humans studyC142564first-in-man studyThe first Phase 1 study in which the test product is administered to human beings.First-in-Human Study
follow-up (clinical study)C156841A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded. [CDISC SDTM Terminology] See also long term follow-up (clinical study).Follow-Up Period
Food and Drug Administration (FDA)C17237The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.Food and Drug Administration
FormC19464A collection of items and item groups for capturing and displaying clinical trial data.Form
frequentist methodsC142565Statistical 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
frozenC142502Status 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)C142438The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. [HL7]Clinical Study Functional Role
functionsC142468functioningThe 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
genderC17357Subject self-identification re: masculine/feminine. [IOM] See also sex.Gender
gene therapyC15238Therapy based on ex vivo or in vivo gene modification of cells using specific technologies, e.g., viral vectors and direct genome editing technologies. NOTE: A particular example of this is the therapy with gene-modified T cells (chimeric antigen receptor (CAR) T-cell therapies) used as immunotherapy in oncology. [After Natalie Mount, et al. Cell-based therapy technology classifications and translational challenge. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19; 370(1680): 20150017.] See also cell therapy, regenerative medicine therapy, regenerative medicine advanced therapy, biological product.Gene Therapy
general observation classC165827In 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,] See also domain, event, intervention, finding. Compare with special purpose domain.CDISC General Observation Class
generalizabilityC142429The 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 nameC97054Nonproprietary NameThe name of a drug based on its chemical and molecular structure. NOTE: In the United States of America, this is assigned by the United States Adopted Names (USAN) council. [After Merck Manual, Consumer Version, 2023] See also proprietary name, international nonproprietary name (INN), established name, medicinal product name, compendial name.Generic Name
global assessment variableC142566A 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
glossaryC18232A collection of specialized words or terms with their meanings.Glossary
Good Clinical Practice (GCP)C94236GCRP;good clinical research practiceA 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
granularityC142567Refers 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 designC142568A 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 signatureC142569The 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 standardC142542A 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)C80485An 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 literacyC176259The degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make health decisions. [After The Patient Protection and Affordable Care Act of 2010, Title V; After What is Health Literacy? Oct 23, 2019]. See also plain language writing.Health Literacy
health-related quality of life (HRQoL)C142570A 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 providerC16666A 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 volunteerC49651A healthy person volunteering to participate as a subject in a clinical study. NOTE: This is often a healthy person agreeing to participate in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 03/30/2023]Healthy Subject
HIE (Health Information Exchange)C156650The 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 subjectC70665subject/trial subjectIndividual 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 LawC142572France's regulations covering the initiation and conduct of clinical trials.Huriet Law
HyperText Markup Language (HTML)C142380A specification of the W3C that provides markup of documents for display in a web browser. [HL7] Contrast to XML.Hypertext Markup Language
hypertextC142573Links in a document that permit browsers to jump immediately to another document. NOTE: In most browsers links are displayed as colored, underlined text.Hypertext
hypothesis to testC142574In 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 conditionC171511A 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 witnessC142577A 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
incidence rateC53348A proportion calculated as the number of individuals who develop the disease during a period of time divided by the number of persons at risk. [After AMA Style Guide, 10th Edition; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] See also morbidity rate, morbidity, mortality, incidence, prevalence.Incidence Rate
incidenceC16726The occurrence of new cases of disease, injury, or disability in a defined population over a specified period of time. NOTE: Incidence is most often expressed relative to the total population at risk (i.e., per unit of population). [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to prevalence. See also morbidity rate, morbidity, mortality, incidence rate.Incidence
inclusion criteriaC25532The 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)C142578A 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)C142579An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [After ICH E6 R2 Glossary] See also institutional review board, ethics committee.Independent Ethics Committee
independent variableC191277A variable that is not affected by other variables that the study is trying to understand. Independent variables influence dependent variables. [After AMA Manual of Style] See also dependent variable.Independent Variable
indicationC41184A 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 identifierC142581quasi identiferData 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 consentC16735An 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
infusionC15388Any form of treatment that is introduced into the body slowly by constant administration or drip via a blood vessel, a muscle, or the spinal cord. [After EDQM Standard Terms controlled vocabularies for pharmaceutical dose forms Version 1.2.0 2019. Internal controlled vocabularies for pharmaceutical dose forms. Version 1.2.0 - 28 January 2019.] See also administration (substance).Infusion Procedure
ingredientC202575Active and/or inactive material used in pharmaceutical product. [After ISO 11615:2017, 3.1.28]Pharmaceutical Product Ingredient
inspectionC142448The 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)C21541Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH]Healthcare Facility
institutional review board (IRB)C16741committee for the protection of human subjects;independent ethics committee;independent review boardAn independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. [ICH E6 1.31]Institutional Review Board
instrumentC142631A 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 useC54390The 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,]Medical Product or Procedure Intent of Use
intention-to-treatC54398The 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 reliabilityC78688The property of scales yielding equivalent results when used by different raters on different occasions. [ICH E9]Inter-rater Reliability
interaction (qualitative and quantitative)C142732The 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
intercurrent eventC188815An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. [ICH E9 Addendum on Estimands]Intercurrent Event
interim analysis scheduleC142583The time/information points at which interim analyses are planned.Interim Analysis Schedule
interim analysis(es)C142582Analysis 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 reportC115555A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH]Interim Analysis Output
internal consistencyC78687Pertaining to data that do not include contradictions.Internal Consistency
international birth date (IBD)C142584The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]International Marketing Authorization Birth Date
international nonproprietary name (INN)C142585Unique name for a drug substance (pharmaceutical ingredient) that is globally recognized and public property. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO, Health products policy and standards, INN and medicines classification] See also proprietary name, generic name, established name, medicinal product name, compendial name, active substance.International Nonproprietary Name
internet service provider (ISP)C142586A company that provides access to the internet for individuals and organizations.Internet Service Provider
internetC20342A global system of computer networks that provides the common TCP IP infrastructure for e-mail, the World Wide Web, and other online activities.Internet
interoperabilityC142381Ability 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
interventionC25218An activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. This is a general term that encompasses the medical, social, behavioral, and environmental acts that can have preventive, therapeutic, or palliative effects. (NCI) See also investigational product, experimental intervention, vaccine, medical device, diagnostic device.Intervention or Procedure
investigational deviceC72968A device that is assessed in a clinical investigation. [REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] See also investigational product, medical device.Investigational Medical Device
investigational medicinal productC202579Investigational ProductA pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Reference products and placebos are also considered investigational medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP) -- Step 4 (final), 9 November 2016 -- Glossary] See also authorised investigational medicinal product, experimental intervention.Investigational Medicinal Product
investigatorC25936An 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 brochureC79303A 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/institutionC142591An 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 (PRO)C142629An 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 definitionC142592Formal specification of the properties of an item or field of data in an eClinical trial. [CDISC ODM, CDISC CDASH]Item Definition
item generationC142630Establishing 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 definitionC142593The 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
itemC142431A 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
Janus conceptual modelC142594A 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 repositoryC142595The 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
labelC41203package insert, patient package leafletDescription 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)C54694All 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)C142432A laboratory providing analyses of samples collected in clinical care or research.Clinical Laboratory
last subject in - date, time (LSI - date, time)C142596last patient in - date, time;LPI - date, timeThe 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)C142597last patient in - identity;LPI - identityThe last subject enrolled in a clinical trial.Last Subject In Identity
last subject last visit - date, time (LSLV - date, time)C142598last 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)C142599last subject complete - identity;last subject out - identity;LPC-dentity;LPO - identity;LSC - identity;LSO - identityThe last subject to reach a planned or achieved milestone representing the completion of the trial.Last Subject Last Visit Identity
legal authenticationC142514A 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 representativeC142600An 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/ experienceC84266Any 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
long term follow-up (clinical study)C16032LTFUPlanned observations that are made over an extended period of time and are a formal phase of a clinical study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study).Long-term Follow-up
longitudinal studyC15273Investigation 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 trialC142601A 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
machine learningC176231A computing system (inspired by biological neural networks) that learns (progressively improves its ability) to do tasks by considering examples without task-specific programming. NOTE: Machine learning algorithms build a mathematical model based on sample data, known as "training data", in order to make predictions or decisions without being explicitly programmed to do so. It is a subset of artificial intelligence. [After DeepAI Machine Learning Glossary and Terms] See also deep learning, artificial intelligence (AI).Machine Learning
manufacturer (device)C156625Any 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)C156626Any 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
mappingC142485In the context of representing or exchanging data, connecting an item or symbol to a code or concept. Compare to translation.Data Mapping
marketing authorization holderC88074Organization 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 procedureC142602Formal 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 authorizationC156642marketing approvalAuthorisation 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 support trialsC142603Clinical 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
markupC63615Computer-processable annotations within a multimedia document. NOTE: in the context of the HL7 specification, markup syntax is according to the XML specification. [HL7]Markup
maskingC191278The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from the comparator. NOTE: Blinding refers to study participants while masking refers to the study intervention. [After Crisp A. Blinding in pharmaceutical clinical trials: An overview of points to consider. Contemp Clin Trials. 2015;43:155-163.] See also blinding.Masking
master protocolC165770A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also umbrella trial design, basket trial design, platform trial design, adaptive design.Master Protocol
matched-pair designC142604A 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
meanC53319The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.Arithmetic Mean
MedDRA (Medical Dictionary for Regulatory Activities)C43820A global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others.MedDRA
medianC28007The 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 countermeasureC171514Pharmaceutical 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 deviceC16830Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps]Medical Device
medical monitorC51836A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.Medical Monitor
medical monitoringC53607Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose. See also monitoring.Patient Monitoring
medication errorC156627Any 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 classificationC156643Categorisation 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 identifierC142606Unique 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 nameC142607Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.Medicinal Product Name
medicinal productC142605Any 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
Medicines and Healthcare products Regulatory agency (MHRA)C142608The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. [MHRA]Medicines And Healthcare Products Regulatory Agency
mega-trialsC142609large sample trialMassive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects.Mega-Trial
memorandum of understanding (MOU)C142553A 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)C142486The 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 protocolC184389The document describing the plan for combining of evidence from relevant studies using appropriate statistical methods to allow inference to be made to the population of interest. NOTE: The most common reason for performing a meta-analysis is to provide an estimate of a treatment effect or measure of relative risk associated with an intervention and to quantify the uncertainty about the estimated effect or risk, when data from a single existing study are insufficient for this purpose. [FDA Draft Guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry, November 2018] See also meta-analysis.Meta-Analysis Protocol Document
meta-analysisC17886The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. NOTE: This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. The methodology for performing the meta-analysis can be found in a meta-analysis protocol, or plan. [After ICH E9 Glossary] See also meta-analysis protocol.Meta-Analysis
metabolismC19536The biochemical alteration of substances introduced into the body.Metabolic Process
metadataC52095Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.Metadata
migrationC142726The 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
minorC156663A 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 dataC142610Data 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
modeC53320The most frequently occurring value in a data set.Mode
modelC16866A 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
modemC50072From 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
moietyC103246An 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
monitorC41201Person 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 planC115753A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. [ICH E6(R2) Glossary Addendum] See also monitoring.Clinical Trial Monitoring Plan
monitoring reportC142708A 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 visitC142709A 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
monitoringC61256Act of overseeing, tracking, observing, evaluating or supervising over time by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring, data monitoring, risk based monitoring.Monitoring
morbidity rateC184382A measure of the frequency of occurrence of a specific disease, injury, or disability in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, incidence, prevalence, mortality rate, incidence rate.Morbidity Rate
morbidityC16877Departure from physiological or psychological health, i.e., disease, injury, or disability. NOTE: Most often measures of morbidity frequency characterize the number of persons in a population who become ill (incidence) or are ill at a given time (prevalence). See also morbidity rate, incidence, prevalence, mortality rate, incidence rate, virulence.Morbidity
mortality rateC16880A measure of the frequency of occurrence of death in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, morbidity rate, incidence, prevalence, incidence rate.Mortality Rate
multicenter trialC16104Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/institution, study.Multi-Institutional Clinical Trial
mutual recognition procedure (MRP)C156635The 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] See also Reference Member State (RMS) and Concerned Member State (CMS).Mutual Recognition Procedure
n-of-1 studyC142614A 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 processingC176260The use of algorithms to determine properties of natural, human language so that computers can understand what humans have written or said. NLP includes teaching computer systems how to extract data from bodies of written text, translate from one language to another, and recognize printed or handwritten words. NOTE: NLP is the field that allows for our everyday use of virtual assistants such as Siri, Alexa, or Google. [After DeepAI Definitions] See also artificial intelligence (AI).Natural Language Processing
natural languageC142612Language 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)C43515A 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)C72899An application to FDA for a license to market a new drug in the United States.New Drug Application
new safety informationC142613Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]New Safety Information
NOEL (no observable effect level)C156651The dose of an experimental drug given preclinically that does not produce an observable toxicity.No Observable Effect Level
nomenclatureC48298Application of naming conventions. Compare to vocabulary, terminology.Nomenclature
non-confirmatory resultC165828In 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-inferiority (NI) trialC184386A type of controlled trial to demonstrate that the new treatment is not less effective than the active control by a specified amount. [After Non-Inferiority Clinical Trials to Establish Effectiveness. FDA Guidance for Industry. November 2016]Non-Inferiority Study
non-interventional studyC142615A 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 studyC48678Biomedical studies not performed on human subjects. [ICH E6 (R2)]Nonclinical Study
not approvable letterC142554An 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)C142545A 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 hypothesisC142616The 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 CodeC142617A code of ethics set forth in 1947 for the conduct of medical research, with the express purpose of protecting human medical research subjects.Nuremberg Code
objectiveC142450The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. [After ICH E8] See also primary objective, secondary objective.Clinical Trial Objective
observationC116555An assessment of patient condition in data collected on an individual patient or group of patients. Note: In SDTM, an observation refers to a discrete piece of information collected during a study, e.g., measures used to assess an outcome. [SDTM] See also variable, outcome.Clinical Observation
observational studyC16084A non-interventional study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate, within a study population, and where the independent variable is not under the control of the researcher. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York;] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial.Observational Study
observer assessmentC142619An 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)C142620A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviors related to a patient's health condition by someone other than the patient or a health professional. [After BEST Resource]Observer-reported Outcome
official protocol titleC132346scientific protocol titleThe formal descriptive name for the protocol sufficient to describe key elements of the study, aimed at a scientific audience. NOTE: The official protocol title should include the study acronym, if applicable [After WHO ICTRP]. The official protocol title should be sufficiently different from other official protocol titles to create brevity with specificity [NIH Protocol Template]. In the case of a master protocol, the study title may be more specific than the protocol title. See also protocol title, public protocol title.Official Protocol Title
ontologyC21270An 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 enrollmentC142621The 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 studyC49659A 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 modelC142622The 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)C142580The judgment and/or the advice provided by an independent ethics committee. [ICH E6 Glossary]Independent Ethics Committee Opinion
original dataC142623The 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)C82521A category of important medical events that may not be immediately life-threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event. Note: These "Other serious" events require medical and scientific judgement in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event.Other Medically Important Serious Event
outcome (of adverse event)C49489Refers 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
outcome measureC93407Specific key measurement(s) or observation(s) used to determine the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. (After BRIDG)Study Outcome Measurement
outcomeC20200The measureable characteristic (clinical outcome assessment, biomarker) that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation.Outcome
outcomes researchC15365Research 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
outliersC79083Values outside of an expected range.Outlier
overdoseC50873Administration 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-valueC44185The probability that the observed data could have arisen by chance when the interventions did not differ. [After AMA Manual of Style] See also null hypothesis.P-Value
packagingC185295The 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 trialsPackaging Materials
pairingC142624matchingA 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
pandemicC171519An 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 trialC82639parallel design trial;parallel group trialA trial design in which subjects are assigned to one of two or more different treatment groups (usually investigational product and placebo) and usually receive the assigned treatment during the entire trial. [After ICH E9; EMA NOTE FOR GUIDANCE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS, September 1998]Parallel Study
parameterC44175A 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
participantC156779A 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 agingC142626A 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 fileC142627One 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
patientC16960Person 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-reported outcome (PRO)C95401A 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 setC142635The 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)C142632A PerfO is a measurement based on a task(s) performed by a patient according to instructions that is administered by a health care professional. NOTE: Performance outcomes require patient cooperation and motivation. These include measures of gait speed (e.g., timed 25 foot walk test), memory recall, or other cognitive testing (e.g., digit symbol substitution test). [After 1. FDA Clinical Outcome Assessment (COA) Glossary; 2. After BEST Resource]Performance Outcome
performed activityC70900Clinical trial events as they actually occurred (as compared with events planned in the protocol).Performed Clinical Study Activity
period effectC142633An effect occurring during a period of a trial in which subjects are observed and no treatment is administered.Period Effect
permanent dataC142634Data 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 valuesC41109Limited universe of options for data items. (e.g., drop-down menus, codelists, pick lists).Permissible Value
personally identifiable information (PII)C90492Any 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 productC42639Qualitative 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
pharmacodynamicsC15720Branch of pharmacology that studies reactions between drugs and living structures, including the physiological responses to pharmacological, biochemical, physiological, and therapeutic agents.Pharmacodynamics
pharmacoeconomicsC142636Branch 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 testC68761An assay intended to study interindividual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.Pharmacogenetic Test
pharmacogeneticsC16973Study of the way drugs interact with genetic makeup or the study of genetic response to a drug.Pharmacogenetics
pharmacogenomic testC68762An 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
pharmacogenomicsC20050Science 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
pharmacokineticsC15299Study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of medicinal products.Pharmacokinetics
pharmacologyC16974Science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.Pharmacology
pharmacovigilanceC142637Process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. NOTE: Pharmacovigilance is a key public health function that comprises: collecting and managing data on the safety of medicines; looking at the data to detect 'signals' (any new or changing safety issue); evaluating the data and making decisions with regard to safety issues; acting to protect public health (including regulatory action);communicating with stakeholders; auditing of both the outcomes of action taken and the key processes involved. [After IDMP] See also postmarketing surveillance.Pharmacovigilance
phase (within a study)C176261A stage in the sequence of activities in a clinical study (e.g., Screening, Randomization, Treatment, Follow-up). See also arm, visit, phase (of clinical development), epoch.Study Phase
phase 0C54721Originally described as an exploratory study with no safety or efficacy targets. It is not cited in current FDA guidance and no longer in common usage. See also phase.Phase 0 Trial
phase 1C15600The initial introduction of an investigational new drug into humans. Phase 1 studies are closely monitored and are most often conducted in normal healthy volunteer subjects but in specific cases also in patients. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after ICH E8; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also phase.Phase I Trial
phase 2C15601Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b.Phase II Trial
phase 2aC49686Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] See also phase, phase 2, phase 2b.Phase IIa Trial
phase 2bC49688Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.] See also phase, phase 2, phase 2a.Phase IIb Trial
phase 3C15602Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b.Phase III Trial
phase 3bC49689Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. See also phase, phase 3.Phase IIIb Trial
phase 4C15603Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase.Phase IV Trial
phase 5C47865Postmarketing surveillance to monitor product safety and efficacy. See also outcomes research, phase, postmarketing surveillance.Phase V Trial
phaseC48281phase (of clinical development)A stage in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development.Trial Phase
placeboC753A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.Placebo
plain language writingC176262Writing in a way that helps readers understand the content in a document the first time they read it. Note: Plain writing is intended to be clear, concise, well-organized, and follow other best practices appropriate to the topic or field and the intended audience. [After Plain Writing Act of 2010, FDA]. See also health literacy.Plain Language Writing
platform trial designC202581A type of trial design under a master protocol framework that tests multiple, targeted therapies that may be adapted over the course of the study. NOTE: Platform trials often include an adaptive design that may eliminate or add treatments based on interim analysis. These trials may also include elements of basket or umbrella trials and may have no pre-determined end date. [After Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.; After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also master protocol, adaptive design.Platform Trial Design
populationC17005Any 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)C142639Studies that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [FDA Webpage Postmarketing Requirements and Commitments: Introduction, 01/12/2016] See also postmarketing requirement. Compare to postmarketing requirement (PMR).Postmarketing Commitment
postmarketing requirement (PMR)C97025FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment (PMC).Post Marketing Requirement
postmarketing surveillanceC142640Ongoing safety monitoring of marketed drugs. See also Phase 4 studies, Phase 5 studies, pharmacovigilance.Postmarketing Surveillance
pragmatic trialC142641A trial that compares health interventions in a diverse population representing clinical practice. These trials inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice. NOTE: These trials may or may not be randomized and can be large simple studies. [After GetReal - Project No. 115546l, WP1: Deliverable D1.3, Glossary of Definitions of Common Terms; Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375:454-63.] See also Real-World Data (RWD), Real-World Evidence (RWE), confirmatory trial.Pragmatic Trial
pre-approval accessC71724A 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)C70880An application to FDA for a license to market a new device in the United States.Pre-market Approval Application
preambleC142555A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: "The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue" raised in comments submitted in response to the proposed regulation. [After 21CFR10.40]FDA Regulation Preamble
preclinical studiesC142642Animal 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
prevalenceC17010The number of the existing cases of disease or injury in a defined population at a given point in time. NOTE: The relation between incidence and prevalence varies among diseases. There may be low incidence and a high prevalence - as for diabetes - or a high incidence and a low prevalence - as for the common cold. [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to incidence. See also morbidity rate, morbidity, mortality, incidence rate.Prevalence
primary completion dateC142643The 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. []Primary Completion Date
primary objectiveC85826The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective, secondary objective.Trial Primary Objective
primary outcome variableC142644An 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 investigatorC19924An 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 breachC156637A 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 doseC95344The 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
PROMISC102988NIH-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
prophylaxisC15843preventionPractices or interventions used to help people stay healthy and avoid disease. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015]Preventive Intervention
proprietary nameC71898Brand Name;Trade NameA commercial name for a drug product, granted by a naming authority for use in marketing a drug/device product. [After SPL; After FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.Proprietary Name
prospective studyC142646A study with planned observations collected predominantly after the start of the study (i.e. forward-looking). Note: Examples are interventional clinical trials, including clinical trials with an adaptive trial design. [After] See also retrospective study, interventional clinical trial, observational study, adaptive design, clinical study.Prospective Study
protected personal data (PPD)C142647Any 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 amendment(s)C132347A 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)C142648Sponsor 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 deviationC50996A 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 NumberC132299Any of one or more unique codes that refers to a specific protocol. NOTE: There may be multiple numbers (National number, coop group number). [EudraCT]Protocol Identifier
protocol referenced documentsC142650Documents that optionally supplement the ICH GCP recommended sections of a protocol giving background information and rationale for the trial. [After ICH E6 1.44] See also protocol.Protocol Referenced Documents
protocol titleC132300The name of a study protocol. NOTE: In most cases the protocol title is the same as the study title but in certain cases the titles may be different. See also official protocol title, public protocol title, master protocol.Protocol Title
protocol violationC142185A 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
protocolC142451clinical protocol;study protocolA document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. [ICH E6 Glossary]Clinical Trial Protocol
proxy (as an origin of outcome measures)C142651A 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 respondentC142652Someone 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 outcomeC142653A 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
pseudonymizationC142654A 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 reliabilityC142655reliability, psychometricThe degree to which a psychometric 'instrument' is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time. NOTE: Reliability pertains to questions concerning whether an instrument is accurate, repeatable, and sensitive. Reliability is distinguished from validation, which answers whether the instrument (e.g., questionnaire) actually measure the selected "construct" (latent variable). For example a balance (scale) is easily understood as a possibly valid instrument to measure body weight. Its reliability would be assessed by measuring the sensitivity, repeatability, and accuracy of the balance. The validity of using the balance for a particular purpose could then be established by comparing the measured reliability to the reliability required for that purpose. [After Patrick, D.L., 2003] Compare to psychometric validation. See also validation, instrument.Psychometric Instrument Reliability
psychometric validationC142656validity, psychometricThe 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
psychometricsC17034The science of assessing the measurement characteristics of scales that assess human psychological characteristics.Psychometrics
public protocol titleC94105brief protocol title;short protocol titleA brief description intended for the lay public in easily understood language. NOTE: Public title may also be referred to as "brief title." [Segen's Medical Dictionary] See also protocol title, official protocol title.Study Protocol Document Version Public Title
qualitative variableC142657One 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)C15381All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH E6 R2 Glossary]Quality Assurance
quality control (QC)C15311The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled. [ICH E6 R2 Glossary]Quality Control
quality of life (QoL)C17047A 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 variableC142658One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum.Quantitative Variable
query managementC142481Ongoing 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 resolutionC142482The closure of a query usually based on information contained in a data clarification.Data Item Query Resolution
queryC142480A 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
questionnaireC17048A 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
raceC17049An 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 productC142659Any 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 allocationC142660Assignment 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 tableC142661Table of numbers with no apparent pattern used in the selection of random samples for clinical trials.Random Number Table
random sampleC142662Members 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
randomizationC25196The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Randomization can be executed according to imposed rules to achieve desired distribution. For example, unequal randomization is used to allocate subjects into groups at a differential rate, e.g., three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study.Randomization
randomized controlled trial (RCT)C46079Randomized Controlled Clinical TrialA well-controlled clinical trial in which subjects are assigned to treatment or control groups according to randomization principles. See randomization. [After FDA and Clinical Drug Trials : A Short History, S.White Junod, 2008; CONSORT statement] See also randomization, clinical trial, controlled study, adequate and well-controlled studies.Randomized Controlled Clinical Trial
raw dataC142663Data 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
RCRIMC142666Regulated 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)C165830Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Evidence (RWE)Real-world Data
Real-World Evidence (RWE)C165831The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. [After FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017; IMI-GetReal Glossary Workgroup, 2016 GetReal - Project No. 115546, WP1: Deliverable D1.3; FDA Draft Guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, OCTOBER 2021] See also Real-World Data (RWD).Real-world Evidence
reconstruction (of a study)C142712For 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
recordC25198In a regulated environment, documented information in any format that is subject to the requirements for data integrity, and should be controlled and maintained. NOTE: The requirements for data integrity are covered by the ALCOA plus principles. [After 21 CFR Part 11, Parts 210, 211, and 212; 21 CFR 312.61 and 312.62] See also data integrity, ALCOA plus, electronic record, control of electronic records, EHR (electronic health record), electronic personal health record (ePHR), EMR (electronic medical record), trustworthy (electronic records), source data, source document.Record
recruitment (investigators)C142590Process used by sponsors to identify, select, and arrange for investigators to serve in a clinical study.Investigator Recruitment Process
recruitment (subjects)C78343Process 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 periodC142664Time period during which subjects are or are planned to be enrolled in a clinical trialRecruitment Period
recruitment targetC142665Number 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)C80496An information model used as the ultimate defining reference for all HL7 standards. [HL7]Reference Information Model
reference member state (RMS)C156641A 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 .html] See also Mutual Recognition Procedure (MRP) and Concerned Member State (CMS).Reference Member State
regenerative medicine advanced therapy (RMAT) designationC165832An 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] See also regenerative medicine therapy (RMT), regenerative medicine.Regenerative Medicine Advanced Therapy Designation
regenerative medicine therapy (RMT)C165833A treatment to repair or replace damaged cells, tissues, or organs, including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. NOTE: RMT may include human gene therapies, genetically modified cells that lead to a sustained effect on cells or tissues, xenogeneic cell products, and any combination product where the biological product constituent part is a regenerative medicine therapy (biologic-device, biologic-drug, or biologic device-drug). [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016;] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.Regenerative Medical Therapy
regenerative medicineC93254A broad field of medicine that endeavors to create living functional human cells, tissues, and organs to repair or replace tissues or organ function lost due to age, disease, damage, or congenital defects. [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016;] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.Regenerative Medicine
registryC93453A 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 applicationC70868Application made to a health authority to investigate, market, or license a new product or indication.Regulatory Application
regulatory authoritiesC88081health authorityBodies 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 trialC165834A trial designed to reduce or eliminate travel by subjects to an investigative site for treatment and completion of study related procedures by implementing virtual visits (e.g., via electronic communication). [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also virtual, decentralized clinical trial.Remote Clinical Trial
repeat ruleC142667Guide for repeating activities specified in protocol, including such features as the number of cycles and the criteria for stopping.Repeat Activity Until Rule
replacementC142738The act of enrolling a new study subject to compensate for a subject who is no longer participating.Trial Subject Replacement
reportC25375A document that presents information in a structured format intended for a specific purpose and recipient. See also final report, interim clinical trial/study report, monitoring report, document (HL7), clinical study (trial) report.Report
rescue medicationsC165835Medicinal 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 hypothesisC142668The 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 riskC142669In 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 optionC142670One 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 synopsisC115629The brief report prepared by biostatisticians summarizing primary (and secondary) efficacy results and key demographic information.Clinical Study Report Synopsis
results posting (results submission)C142671The 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 results database. []Results Posting
results posting date (results submission date)C142672The 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 results database. []Results Posting Date
retrospective data captureC142673Capture 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 studyC53312A study with planned observations collected predominantly before study start (i.e. backward-looking). Note: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [after] See also prospective study, observational study, adaptive design, clinical study.Retrospective Study
RHIO (Regional Health Information Organization)C156652A 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 based monitoringC142674A systematic, prioritized, risk-based approach to monitoring clinical trials. [After ICH E6(R2), 5.18.3]Risk Based Monitoring
riskC142718In 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
role (CDISC classifier)C142414Classifier 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)C38114Path 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
SAFEC142675BioPharma(TM) Digital Identity and Signature Standard.SAFE-Biopharma Standard
safety and tolerabilityC142676The 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
safetyC60828Relative 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
sample size adjustmentC142677An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9]Sample Size Adjustment
sample size calculationC115467A 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
sample sizeC53190A subset of a larger population, selected for investigation to draw statistically valid conclusions or make estimates about the larger population. NOTE: This number is presented in the protocol and statistical analysis plan. [After ICH E9]Sample Size
schedule of activitiesC132349Schedule of Events;SoAA 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 assessmentsC142678A 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 failureC49628At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary]Trial Screen Failure
screen/screening (of substances)C142721Screening 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)C142689Determining the suitability of an investigative site and personnel to participate in a clinical trial.Site Screening
screening (of subjects)C48262A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure.Trial Screening
screening (period)C202487A period in a clinical study during which subjects are evaluated for participation in the study. See also screening (of subjects)Screening Epoch
screening trialsC71485A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). ( Study
scriptC96999A program or a sequence of instructions that are interpreted or carried out by another program or by a person.Script
secondary objectiveC85827Secondary objectives are supportive or ancillary questions of interest in a trial that will provide further information on the use of the treatment. See also primary objective, objective.Trial Secondary Objective
secondary outcome variableC142680Data 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 sponsorC142679Additional 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 changeC142681A 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 interoperabilityC142682The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308]Semantic Interoperability
semanticC54194In 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
SEND (standard for the exchange of nonclinical data)C156653The 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 dataC142683Any 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 reactionC142685Adverse 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)C41335Adverse 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)C142686Any experience that suggests a significant hazard, contra-indication, side effect or precaution. See also serious adverse event.Serious Adverse Experience
serious breachC156636A 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 riskC142687Risk of a serious adverse drug experience. [505-1(b) of FD&C Act (21 USC. 355-1(b)]Serious Risk
serverC48297A 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
severeC70667An 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
sexC28421Phenotypic expression of chromosomal makeup that defines a study subject as male, female, or other. Compare to gender.Sex
side effectsC2861Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction.Side Effect
signC53458An observation by a medical professional obtained from examination, test result, or questionnaire that indicates a patient may have a disease. NOTE: Some examples of signs are fever, swelling, skin rash, high blood pressure, and high blood glucose. [After NCI Glossary] See also diagnosis, symptom.Sign
signal of a serious riskC142688Information 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 studyC28233single-masked studyA 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 productC165836A 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 investigatorC51873A 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)C53489A 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 circumstancesC20188A 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 as a medical device (SaMD)C165837Software 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 validationC142690Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. NOTE: Validating software thus should include evaluation of the suitability of the specifications to "ensure user needs and intended uses can be fulfilled on a consistent basis" (21 CFR 820.20). General Principles of software Validation; Final Guidance for industry and FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a); ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually concerns confirmation that specified requirements have been met, but typically refers to the tracing of requirements and evidence of conformance in the individual phases or modules rather than suitability of the complete product. Validation is, "the evaluation of software at the end of the software development process to ensure compliance with the user requirements" (ANSI/ASQC A3-1978) and should not be thought of as an "end-to-end" verification. See also validation.Software Validation
software verificationC91996The 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
softwareC17146Computer programs, procedures, rules, and any associated documentation pertaining to the operation of a system.Computer Program
source data verificationC142752The process of ensuring that data that have been derived from source data accurately represent the source data.Source Data Verification
source dataC125442All 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 document verification (SDV)C142693The 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 documentsC142692Original 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
sourceC25683The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. NOTE: The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. Accuracy, suitability, and trustworthiness are not defining attributes of "source." The term is also sometimes used as shorthand for source documents and/or source data. [After ICH E6, CSUICI] See also source document, source data, original data, certified copy.Source
special populationsC18101Subsets 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 domainC165838In 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,] See also domain, general observational class.Special Purpose Domain
specified substanceC142694Substance 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
sponsorC70793An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.Clinical Study Sponsor
sponsor-investigatorC142695An 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 deviationC53322Indicator of the relative variability of a variable around its mean; the square root of the variance.Standard Deviation
standard of careC94396A guideline for medical management and treatment.Best Practice
standard operating procedures (SOPs)C48443Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH]Standard Operating Procedure
standard treatmentC142696A 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
standardC81893technical standardA 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,]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.Standard
Standards Development Organization (SDO)C165839A 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 planC115761A 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 distributionC53206A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style]Statistical Distribution
statistical methodC19044The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998]Statistical Technique
statistical significanceC61040The likelihood that an event occurs by chance (e.g., hypothesis is rejected). Whether or not a given result is significant depends on the significance level adopted. NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.Statistical Significance
stemC142628The prompt, question, or instruction in a PRO item. See also response option, item.Patient Reported Outcome Stem
stochasticC142697Involving a random variable; involving chance or probability.Stochastic
stopping rulesC142698A 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
stratificationC25689Grouping defined by important prognostic factors measured at baseline. [ICH E9]Stratification
structured dataC142699Data that have been organized into discrete fields, and may be enumerated, numeric, or codified.Structured Data
structured health record informationC184388Structured health record information is organized into discrete fields, and may be enumerated, numeric, or codified. Examples of structured health information include: patient address (non-codified, but discrete field); diastolic blood pressure (numeric); coded result observation; coded diagnosis; patient risk assessment questionnaire with multiple-choice answers. Context may determine whether or not data are unstructured, e.g., a progress note might be standardized and structured in some eHR-s (e.g., subjective/objective/ assessment/Plan) but unstructured in others. [HL7 eHR-s FM Glossary of Terms, 2010].Structured Health Record Information
structured product label (SPL)C142700The 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 dateC142702The 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 Completion Date
study completionC70756As 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 Data Standardization Plan (SDSP)C165840A 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,,] See also standards, data standards, CDISC standards, and Standards Development Organization.Study Data Standardization Plan
study descriptionC142704Representation of key elements of study (e.g., control, blinding, gender, dose, indication, configuration).Study Description
study design rationaleC142705Reason(s) for choosing the study design. NOTE: Reasons may include the choice of control, comparator or population, as well as the scientific or statistical rationale.Study Design Rationale
study design schematicC93682A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. [CDISC Terminology; After ICH E3]Study Schematic
study designC15320Plan 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 monitoringC142707Trial MonitoringThe act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring.Study Monitoring
study participantC142710A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, data subject, clinical research subject, participant.Study Participant
study populationC70833A 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 dateC142711The 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. []Study Publication Date
study report completion dateC142713The 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 dateC69208The date on which the protocol-defined study start criteria are met. NOTE: The US FDA defines the study start date for clinical studies as the earliest date of informed consent among any subject that enrolled in the study. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021]Study Start Date
study startC142714The criteria for study start, as defined in the protocol, are met.Study Start
study variableC142192A term used in trial design to denote a variable to be captured on the CRF. See also variable.Study Variable
sub-investigatorC54622Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [After ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.Subinvestigator
subject completionC70735The 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 eventC142717A subject visit or other encounter where subject data are collected, generated, or reviewed. [SDTM]Subject Data Event
subject identification codeC70731A 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 monitoringC156639Act 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 contactC142638Any 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)C21089An outcome reported directly by a subject in a clinical trial. [Patrick, D.l., 2003] See also patient-reported outcome (PRO).Patient Self-Report
submission modelC142496A 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 trialC142722A 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 (system)C142459An organization that enters into a contract with the acquirer for the supply of a system (such as a software product, or software service) under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30]Computer System or Software Supplier
surrogate endpointC68772An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource]. See also endpoint.Surrogate Endpoint
surrogate markerC142724A measurement of a drug's biological activity that substitutes for a clinically meaningful endpoint. [After Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, NeuroRx. 2004 Apr;1(2):189-95.]Surrogate Marker
surrogate variableC142725A 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
surveyC17176Any 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)C156631An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).Clinical Trial Suspension
symptomC4876An experience reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign.Symptom
synopsisC68836Brief 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
syntacticC54277The 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
synthetic dataC176263Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence.Synthetic Data
systemC25700People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI]System
t-testC53231A statistical test used to compare the means of two groups of test data.t-Test
table of roles and responsibilitiesC125429A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials.Clinical Trial Roles and Responsibilities Matrix
tabulation datasetC142727A 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 enrollmentC49692The number of subjects in a cohort and in the entire study intended to be enrolled to reach the planned sample size. NOTE: Target enrollments are set by sample size calculations so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by algorithm or other specified process. [After ICH E9; After] See also sample size.Planned Subject Number
target populationC142728Population 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 providerC142729technology vendorA 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)C156630An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial).Clinical Trial Temporary Halt
termC45559One 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 a clinical trial)C142739Discontinuation of a trial prior to plan as defined in the protocol. NOTE: Additional information can be found in Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual: Premature Termination or Suspension of a Clinical Trial, 19 January 2021. See also discontinuation, suspension (of a clinical trial), clinical hold (of a clinical trial), temporary halt (of a clinical trial).Trial Termination
terminologyC142730Set 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 areaC101302A category for a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention. (After NCI)Therapeutic Area
therapeutic indexC18223The 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
tokenC67478Physical key that provides access to a secure electronic system or location.Token
traceability (data)C165841The 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
transcriptionC142497Process 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 ruleC82567A 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
translationC80450Converting information from one natural language to another while preserving meaning. Compare to mapping.Translation
translational researchC15862The 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
transmitC142499To 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 benefitC142731The 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
treatmentC49236therapyMedical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis.Therapeutic Procedure
treatment-emergent adverse eventC142733An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. [ICH E9]Treatment-Emergent Adverse Event
trial design elementC142735A 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 ModelC142736Defines 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 siteC85838The 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 statisticianC142737A 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 studyC66959A 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)C142740An 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) errorC45726false positiveError made when a null hypothesis is rejected but is actually true.False Positive
type 2 (or type II) errorC93283false negativeError made when an alternative hypothesis is rejected when it is actually true.False Negative
type 3 (or type III) errorC142741Some statisticians use this designation for an error made when calling the less effective treatment the more effective treatment.Type 3 Error
type of comparisonC142576How 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 trial designC202589A type of trial design under a master protocol designed to evaluate multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022]. See also master protocol.Umbrella Trial Design
unblindingC142742Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023]Unblinding
unexpected adverse drug reactionC142744An 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 riskC142745A 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)C42743Address of a web page, for example, Resource Locator
use caseC81930An 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)C156628User 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)C142746Any 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
vaccine effectivenessC184385Vaccine protection measured in observational studies that include people with underlying medical conditions who have been administered vaccines by different health care providers under real-world conditions. [How Flu Vaccine Effectiveness and Efficacy are Measured, Questions & Answers, CDC January 29, 2016] See also vaccine efficacy, efficacy, effectiveness, randomized controlled trial (RCT).Vaccine Effectiveness
vaccine efficacyC184384The proportional comparison of infection rate or other disease endpoints between vaccinated and unvaccinated groups measured in randomized controlled trials. NOTE: The method for calculating vaccine efficacy can be found here: Efficacy is a measurement made during a clinical trial, effectiveness is how well the vaccine works out in the real world. [After Greenwood et al., Proc R Soc Med. 1915; 8 (Sect Epidemiol State Med): 113-194, The Statistics of Anti-typhoid and Anti-cholera Inoculations, and the Interpretation of such Statistics in general. After Piero Ollario, The Lancet Infectious Diseases, Feb 17th, 2021] See also vaccine effectiveness, effectiveness, efficacy, randomized controlled trial (RCT).Vaccine Efficacy
vaccineC923A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). NOTE: The vaccines against infectious disease may contain various ingredients of diverse origin (such as inactivated or attenuated organisms, particular antigens related to the infectious agent, live recombinant vector against antigens in vivo and adjuvants) [After NCI Dictionary of Cancer Terms. After European Pharmacopoeia section 5.1.] See also treatment, prevention, prophylaxis, biological product, virulence.Vaccine
validC71756SoundWell grounded on principles of evidence. [After FDA Glossary of Computerized System and Software Development Terminology]Valid
validationC16237validityProcess of establishing suitability to purpose. NOTE: Validation is accomplished by planning how to measure and/or evaluate suitability to purpose; then executing the plan and documenting the results. [ICH E6] See also software validation, data validation, psychometric validation, criterion validation (COA), content validation (COA), construct validation (COA).Validation
variableC54166Any attribute, phenomenon, characteristic, or event that can have different qualitative or quantitative values. [After Statistical Language - What are Variables?, Australian Bureau of Statistics, October 2013] See also dependent variable, derived variable, global assessment variable, primary outcome variable, qualitative variable, quantitative variable, secondary outcome variable, study variable, supporting variables, surrogate variable.Variable
varianceC48918A 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 of dataC142501The 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
verificationC45513The 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
virtualC176264Connected but not physically co-located. NOTE: Refers to visits or encounters between investigators and subjects where information exchange is mediated through telemedicine, video conference rather than by physical presence of individuals at a shared location. Trials with one or more virtual visits are virtual trials. Where all data capture and trial procedures are conducted virtually, a trial or other investigation may be called fully virtual. [After FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards March 2020 Updated on July 2, 2020] See also remote clinical trial, decentralized clinical trial.Virtual
virulenceC28198The ability of an infectious agent to cause severe disease, measured as the proportion of persons with the disease who become severely ill or die. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014] See also morbidity, vaccine.Virulence
visitC191214Study VisitA protocol-defined clinical encounter that encompasses planned and contingent study interventions, procedures, and assessments that may be performed on a subject. [SDTM]Study Visit
vocabularyC92442The collection of terms, which refer to concepts, that are used by, understood by, or available for use by an individual or group within a language system. [After NCI Thesaurus]Vocabulary
vulnerable subjectsC142747Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [After ICH E6 R2 Glossary] See also human subject, patient, human subject, data subject, clinical research subject, participant, study participant.Vulnerable Subjects
Warning LetterC142556A 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 periodC42872A 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 browserC142748A computer program that interprets HTML and other Internet languages and protocols and displays web pages on a computer monitor.Web Browser
web pageC142749A single page on a website, such as a home page.Web Page
web serverC142750A computer server that delivers HTML pages or files over the World Wide Web. See also server.Web Server
websiteC67518A 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
weightingC48192An adjustment in a value based on scientific observations within the data.Importance Weight
well-being (of the trial subjects)C142720The physical and mental integrity of the subjects participating in a clinical trial. [ICH]Subject Well-Being
withdrawalC49634The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, September 21, 2010] See also discontinuation.Withdrawal by Subject
within-subject differencesC67498In a crossover trial, variability in each subject is used to assess treatment differences.Intra Subject Variability
World Wide WebC20461All the resources and users on the Internet that are using HTTP protocols. Also called the web and www.World Wide Web
XML (eXtensible Markup Language)C45967A set of rules for encoding documents and data in a format that is both human readable and machine readable. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019; After W3C Extensible Markup Language (XML)] See also eXtensible markup language (XML) data element, Define-XML.Extensible Markup Language
zoonosisC35803An infectious disease that is transmissible from animals to humans. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014]Zoonotic Infection
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