Release Date	Request Code	Change Type	NCI Code	CDISC Term Type	CDISC Codelist (Short Name)	CDISC Codelist (Long Name)	Change Summary	Original	New	Change Implementation Instructions
2020-12-18	CDISC-4678	Add	C15197	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	case-control study	
2020-12-18	CDISC-4678	Add	C15220	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	diagnosis	
2020-12-18	CDISC-4678	Add	C15238	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	gene therapy	
2020-12-18	CDISC-4678	Add	C15843	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	prophylaxis	
2020-12-18	CDISC-4678	Add	C16084	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	observational study	
2020-12-18	CDISC-4678	Add	C16309	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	artificial intelligence (AI)	
2020-12-18	CDISC-4678	Add	C176231	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	machine learning	
2020-12-18	CDISC-4678	Add	C176257	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	decentralized clinical trial (DCT)	
2020-12-18	CDISC-4678	Add	C176258	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	deep learning	
2020-12-18	CDISC-4678	Add	C176259	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	health literacy	
2020-12-18	CDISC-4678	Add	C176260	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	natural language processing	
2020-12-18	CDISC-4678	Add	C176261	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	phase (within a study)	
2020-12-18	CDISC-4678	Add	C176262	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	plain language writing	
2020-12-18	CDISC-4678	Add	C176263	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	synthetic data	
2020-12-18	CDISC-4678	Add	C176264	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	virtual	
2020-12-18	CDISC-4678	Add	C25375	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	report	
2020-12-18	CDISC-4678	Add	C307	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	biological product	
2020-12-18	CDISC-4678	Add	C45967	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	XML (eXtensible Markup Language)	
2020-12-18	CDISC-4678	Add	C53310	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	cross-sectional study	
2020-12-18	CDISC-4678	Add	C70601	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	cell therapy	
2020-12-18	CDISC-4678	Add	C923	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	vaccine	
2020-12-18	CDISC-4678	Add	C96966	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	emergency use authorization	
2020-12-18	CDISC-4678	Remove	C142611	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	multicenter study	- - -	Remove C142611 from codelist. Please reference existing term C16104/Multicenter Trial.
2020-12-18	CDISC-4678	Remove	C142719	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	termination (of subject)	- - -	Remove C142719 from list. This term is antiquated. Please reference existing term C142444/discontinuation.
2020-12-18	CDISC-4678	Remove	C142723	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	supporting variables	- - -	Remove C142723 from list. This is not used much in practice anymore. Please reference existing term C54166/variable.
2020-12-18	CDISC-4678	Remove	C142743	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	unequal randomization	- - -	Remove C142743 from list. Please reference existing term C25196/randomization.
2020-12-18	CDISC-4678	Remove	C25320	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	clinical protocol	- - -	Remove C25320 from list. Please reference existing term C142451/protocol.
2020-12-18	CDISC-4678	Remove	C51880	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	study coordinator	- - -	Remove C51880 from list. Please reference existing term C51811/clinical research coordinator (CRC).
2020-12-18	CDISC-4678	Update	C116555	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. an assessment of patient condition or analysis of data collected on an individual patient or group of patients. 2. (SDTM) a discrete piece of information collected during a study. NOTE: observations (meaning 1) are required by protocol (e.g., require evaluation of patient or data by investigator/staff). such planned observations are typically distinguished from anecdotal comments noted during a clinical trial (which qualify as observations under meaning 2). See also variable. Referring to an ad hoc comment as an observation is colloquial. [1. CONSORT statement. 2. SDTM]	An assessment of patient condition in data collected on an individual patient or group of patients. Note: In SDTM, an observation refers to a discrete piece of information collected during a study, e.g., measures used to assess an outcome. [SDTM] See also variable, outcome.	
2020-12-18	CDISC-4678	Update	C142379	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. NOTE: Although data capture is often used synonymously, capture implies direct entry of original source data into an electronic record rather than transcription (entry) from paper source. Contrast with data acquisition, electronic data capture; direct entry. See data collection.	Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. Contrast with data acquisition, electronic data capture, direct entry. See also data collection, data capture.	
2020-12-18	CDISC-4678	Update	C142450	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). Secondary objectives are goals of a trial that will provide further information on the use of the treatment.	The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. See also primary objective, secondary objective.	
2020-12-18	CDISC-4678	Update	C142451	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	clinical protocol	
2020-12-18	CDISC-4678	Update	C142470	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	See data entry.	The process of collecting and recording measures and assessments for a specific purpose. NOTE: Data are said to be captured when they are extracted as permanent records for use in a new context or created as a source document in that context. An example would be data that are manually copied or otherwise extracted from an EHR that are then transferred into a clinical trial database to be used for a clinical trial. [After Working with Data, Australian National Data Service, Accessed 4 Sept 2020; AFter FDA Guidance on Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry, July 2018] See also data entry, EDC (electronic data capture).	
2020-12-18	CDISC-4678	Update	C142500	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. Checking data for correctness and/or compliance with applicable standards, rules, and conventions. 2. Process used to determine if data are inaccurate, incomplete, or unreasonable. The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [1. FDA. 2. ISO]	Process used to determine whether data are accurate, authentic, complete, and/or compliant with applicable standards, rules, and conventions. NOTE: The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [After FDA.; ISO] See also data integrity, validation.	
2020-12-18	CDISC-4678	Update	C142506	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A table in XML that transmits metadata that describes any tabular dataset structure. NOTE: When used with the CDISC content standards, it provides the metadata for human and animal model tabular datasets such as SDTM, SEND, and ADaM. [After CDISC.org]	A table in XML that transmits metadata that describes any tabular dataset structure. NOTE: When used with the CDISC content standards, it provides the metadata for human and animal model tabular datasets such as SDTM, SEND, and ADaM. [After CDISC.org] See also eXtensible markup language (XML) data element, XML (eXtensible Markup Language).	
2020-12-18	CDISC-4678	Update	C142517	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The strength of a drug product, which indicates the amount of active ingredient in each dose. For liquids, it is the proportion of active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms]	The strength of a drug product, which indicates the amount of each active ingredient in a single dose. For liquids, it is the proportion of each active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms]	
2020-12-18	CDISC-4678	Update	C142527	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. See also data entry, direct data entry, data acquisition.	The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018] See also data entry, direct data entry, data acquisition, data capture.	
2020-12-18	CDISC-4678	Update	C142541	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	See institutional review board, independent ethics committee.	Group convened to protect research subjects. NOTE: Such bodies, depending on the country or region, are abbreviated as: CCI, CCPPRB, CHR, CPPHS, CRB, EAB, HEX, HSRC, LREC, MREC, NIRB, NRB, and REB. See also institutional review board, independent ethics committee.	
2020-12-18	CDISC-4143	Update	C142548	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [FDA - GL/IEEE]	For XML, an item of data provided in a mark-up mode to allow machine processing. NOTE: The mark-up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019] See also XML (eXtensible Markup Language), Define-XML.	
2020-12-18	CDISC-4678	Update	C142579	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [ICH] See also institutional review board.	An independent body (a review board or a committee, institutional, regional, national, or supranational) constituted of medical/scientific professionals and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. NOTE: The legal status, composition, function, operations, and regulatory requirements pertaining to independent ethics committees may differ among countries but should allow the independent ethics committee to act in agreement with GCP as described in the ICH guideline. [ICH] See also institutional review board, ethics committee.	
2020-12-18	CDISC-4678	Update	C142646	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Investigation in which a group of subjects is recruited and monitored, and from whom data are collected, in accordance with criteria described in the protocol.	A study with planned observations collected predominantly after the start of the study (i.e. forward-looking). Note: Examples are interventional clinical trials, including clinical trials with an adaptive trial design. [After ClinicalTrials.gov] See also retrospective study, interventional clinical trial, observational study, adaptive design, clinical study.	
2020-12-18	CDISC-4678	Update	C142690	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. NOTE: Validating software thus should include evaluation of the suitability of the specifications to "ensure user needs and intended uses can be fulfilled on a consistent basis" (21 CFR 820.20). General Principles of software Validation; Final Guidance for industry and FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a); ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually concerns confirmation that specified requirements have been met, but typically refers to the tracing of requirements and evidence of conformance in the individual phases or modules rather than suitability of the complete product. Validation is, "the evaluation of software at the end of the software development process to ensure compliance with the user requirements" (ANSI/ASQC A3-1978) and should not be thought of as an "end-to-end" verification.	Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. NOTE: Validating software thus should include evaluation of the suitability of the specifications to "ensure user needs and intended uses can be fulfilled on a consistent basis" (21 CFR 820.20). General Principles of software Validation; Final Guidance for industry and FDA staff, Jan 11, 2002. ISOIEC/IEEE 12207:1995 3.35; 21 CFR 820.20; 21 CFR 11.10(a); ISO 9000-3; Huber, l. (1999) See also validation, verification. Verification usually concerns confirmation that specified requirements have been met, but typically refers to the tracing of requirements and evidence of conformance in the individual phases or modules rather than suitability of the complete product. Validation is, "the evaluation of software at the end of the software development process to ensure compliance with the user requirements" (ANSI/ASQC A3-1978) and should not be thought of as an "end-to-end" verification. See also validation.	
2020-12-18	CDISC-4678	Update	C142710	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, human subject, data subject, clinical research subject, participant.	A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, data subject, clinical research subject, participant.	
2020-12-18	CDISC-3344	Update	C142715	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Status assigned to a subject who agrees to participate in a study,  following completion of the informed consent process and meeting inclusion criteria. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. [after Clinicaltrials.gov]. NOTE: A less common definition assigns enrolled status is the point of enrollment, Can be defined from the signing of an informed consent form. Other ways of defining enrollment or subject status can be specified in some protocols, e.g. non-interventional studies. See also informed consent.	Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. A less common definition confers enrolled status at the signing of an informed consent form, e.g., Clinicaltrials.gov. See also informed consent, enrollment.	
2020-12-18	CDISC-4678	Update	C142739	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Premature discontinuation of a trial prior to plan. [EU Clinical Trial Directive]	Discontinuation of a trial prior to plan as defined in the protocol. See also discontinuation, suspension (of a clinical trial).	
2020-12-18	CDISC-4678	Update	C142739	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	Discontinuation of Trial	
2020-12-18	CDISC-4286	Update	C15208	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [AMA Manual of Style] See also prospective study.	Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study.	
2020-12-18	CDISC-4678	Update	C156632	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Establishing from qualitative research the extent to which the clinical outcome assessment instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]	Establishing from qualitative research the extent to which the clinical outcome assessment (COA) instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.	
2020-12-18	CDISC-4678	Update	C156632	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	content validation (re COA)	
2020-12-18	CDISC-4678	Update	C156633	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment conform to a priori hypotheses concerning logical relationships that should exist with other measures or characteristics of patients and patient groups. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]	Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment (COA) conform to a priori hypotheses concerning logical relationships that should exist with other measures or characteristics of patients and patient groups. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.	
2020-12-18	CDISC-4678	Update	C156633	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	construct validation (re COA)	
2020-12-18	CDISC-4678	Update	C156634	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Establishing the extent to which the scores of a clinical outcome assessment instrument are related to a known gold standard measure of the same concept. For most COAs, criterion validity cannot be measured because there is no gold standard. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]	Establishing the extent to which the scores of a clinical outcome assessment instrument are related to a known gold standard measure of the same concept. For most COAs clinical outcome assessments (COAs), criterion validity cannot be measured because there is no gold standard. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.	
2020-12-18	CDISC-4678	Update	C156634	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	criterion validation (re COA)	
2020-12-18	CDISC-4678	Update	C16104	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/ institution.	Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/institution, study.	
2020-12-18	CDISC-4678	Update	C16237	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Process of establishing suitability to purpose. NOTE: Validation is accomplished by planning how to measure and/or evaluate suitability to purpose; then executing the plan and documenting the results. [ICH E6] See also software validation.	Process of establishing suitability to purpose. NOTE: Validation is accomplished by planning how to measure and/or evaluate suitability to purpose; then executing the plan and documenting the results. [ICH E6] See also software validation, data validation, psychometric validation, criterion validation (COA), content validation (COA), construct validation (COA).	
2020-12-18	CDISC-4678	Update	C165770	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A trial design that tests multiple drugs and/or multiple subpopulations in parallel under a single protocol, without the need to develop new protocols for every trial. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.] See also umbrella protocol, basket protocol, platform protocol.	A trial design that tests multiple drugs and/or multiple subpopulations in parallel under a single protocol, without the need to develop new protocols for every trial. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.] See also umbrella protocol, basket protocol, platform protocol, adaptive design.	
2020-12-18	CDISC-4678	Update	C165833	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A treatment to repair or replace damaged cells, tissues, or organs, including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. NOTE: RMT may include human gene therapies, genetically modified cells that lead to a sustained effect on cells or tissues, xenogeneic cell products, and any combination product where the biological product constituent part is a regenerative medicine therapy (biologic-device, biologic-drug, or biologic device-drug). [After https://www.sciencedirect.com/topics/engineering/regenerative-medicine and http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation.	A treatment to repair or replace damaged cells, tissues, or organs, including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products. NOTE: RMT may include human gene therapies, genetically modified cells that lead to a sustained effect on cells or tissues, xenogeneic cell products, and any combination product where the biological product constituent part is a regenerative medicine therapy (biologic-device, biologic-drug, or biologic device-drug). [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine, regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.	
2020-12-18	CDISC-4539	Update	C165834	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A trial designed to reduce or eliminate travel by subjects to an investigative site for treatment and completion of study related procedures by implementing virtual (e.g., not physically present) visits via electronic communication.	A trial designed to reduce or eliminate travel by subjects to an investigative site for treatment and completion of study related procedures by implementing virtual visits (e.g., via electronic communication). [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also virtual, decentralized clinical trial.	
2020-12-18	CDISC-4678	Update	C20200	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. (SDTM) The result of carrying out a mathematical or statistical procedure. NOTE: 1. such events and experiences are called clinical outcomes independently of whether they are part of the original question/protocol of the investigation. [1. Guyatt, G., Schunemann H., Dept. epidemiology & statistics, McMaster University-personal communication] See also variable; outcome can be a result of analysis; outcome is more general than endpoint in that it does not necessarily relate to a planned objective of the study.outcome. The measureable characteristic (clinical outcome assessment, biomarker) that is influenced or affected by an individual's baseline state or an intervention as in a clinical trial or other exposure. [BEST Resource]	The measureable characteristic (clinical outcome assessment, biomarker) that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation.	
2020-12-18	CDISC-4678	Update	C25196	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study.	The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Randomization can be executed according to imposed rules to achieve desired distribution. For example, unequal randomization is used to allocate subjects into groups at a differential rate, e.g., three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study.	
2020-12-18	CDISC-4678	Update	C25218	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). See also test articles, devices, drug product, medicinal product, combination product, general observation class, finding, event.	The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224] See also test articles, devices, drug product, medicinal product, combination product, general observation class, finding, event, treatment, diagnosis.	
2020-12-18	CDISC-4678	Update	C25683	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. 2. Sometimes used as shorthand for source documents and/or source data. NOTE: Accuracy, suitability, and trustworthiness are not defining attributes of "source." The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. See also original data, certified copy. [After ICH E6, CSUICI]	The specific permanent record(s) upon which a user will rely for the reconstruction and evaluation of a clinical investigation. NOTE:  The term identifies records planned (designated by the protocol) or referenced as the ones that provide the information underlying the analyses and findings of a clinical investigation. Accuracy, suitability, and trustworthiness are not defining attributes of "source." The term is also sometimes used as shorthand for source documents and/or source data.  [After ICH E6, CSUICI] See also source document, source data, original data, certified copy.	
2020-12-18	CDISC-4172	Update	C2861	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any actions or effects of a drug or treatment other than the intended effect. negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. experimental drugs must be evaluated for both immediate and long-term side effects. See also adverse reaction.	Any actions or effects of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects. [After Spilker, B. Guide to Clinical Trials. Lippincott Williams & Wilkins. 2000. Page xxiv; Finding and Learning about Side Effects (adverse reactions), July 2018; What are side effects?, August 2018] See also adverse reaction.	
2020-12-18	CDISC-4678	Update	C2991	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any deviation from or interruption of the normal structure or function of a part, organ, or system of the body as manifested by characteristic symptoms and signs. [Dorland's Medical Dictionary]	Any abnormal condition of the body or mind that causes discomfort, dysfunction, or distress to the affected person. NOTE: The term is often used broadly to include injuries, disabilities, syndromes, symptoms, deviant behaviors, and atypical variations of structure and function. [After NCI Thesaurus] See also diagnosis.	
2020-12-18	CDISC-3344	Update	C37948	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. See also enrolled.	The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. [After Glossary Of Terms On Clinical Trials For Patient Engagement Advisory Committee Meeting] See also enrolled.	
2020-12-18	CDISC-4678	Update	C45259	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11).	An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs (or EHRs) may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11). [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018]	
2020-12-18	CDISC-4678	Update	C45970	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. The process of rendering data into a form that does not identify individuals and where identification is not likely to take place. A general term for a process of removing the association between a set of identifying data and the data subject. 2. Removal of elements connected with data which might aid in associating those data with an individual. Examples include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [1. ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; 2. HIPAA: 45 CFR, 164.514]	The process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. NOTE: A general term for a process of removing the association between a set of identifying data and the data subject. Examples of potentially identifying data include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [After ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; HIPAA: 45 CFR, 164.514] See also anonymization.	
2020-12-18	CDISC-4678	Update	C48281	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	One in a set of successive stages in a progression or sequence such as 1. a step in the progression of a therapy from initial experimental use in humans to postmarket evaluation. 2. a stage in the conduct of a clinical trial. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. For meaning 1, see Phase 0-5. For meaning 2, see epoch.	A step 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] See also Phase 0-5, epoch (if reference is to a single trial), phase (within a study), clinical research and development.	
2020-12-18	CDISC-4678	Update	C48281	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	phase (of clinical development)	
2020-12-18	CDISC-4678	Update	C49236	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	therapeutic intervention	treatment	
2020-12-18	CDISC-4678	Update	C49236	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	See intervention.	Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis.	
2020-12-18	CDISC-4678	Update	C49236	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	therapy	
2020-12-18	CDISC-4678	Update	C51811	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor's visit. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator	Study site staff member who executes, manages, and coordinates research protocols in the clinic setting including screening, enrollment, monitoring of patient candidates/participants, and administration of informed consent. Other duties may be included depending on the study site.	
2020-12-18	CDISC-4678	Update	C53312	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A type of study in which analyses are carried out, according to a protocol, at the present time that looks to the past to examine medical events or outcomes. Data that were previously collected or analyzed are subjected to analysis for a new and different purpose. [After Song JW, Chung KC. Observational studies: cohort and case-control studies. Plast Reconstr Surg. 2010 Dec;126(6):2234-42.]	A study with planned observations collected predominantly before study start (i.e. backward-looking). Note: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [after ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study.	
2020-12-18	CDISC-4678	Update	C54166	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any entity that varies; any attribute, phenomenon, or event that can have different qualitative or quantitative values.	Any attribute, phenomenon, characteristic, or event that can have different qualitative or quantitative values. [After Statistical Language - What are Variables?, Australian Bureau of Statistics, October 2013] See also dependent variable, derived variable, global assessment variable, primary outcome variable, qualitative variable, quantitative variable, secondary outcome variable, study variable, supporting variables, surrogate variable.	
2020-12-18	CDISC-4678	Update	C71738	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Interval of time in the planned conduct of a study. An epoch is associated with a purpose (e.g., screening, randomization, treatment, follow-up), which applies across all arms of a study. NOTE: Epoch is intended as a standardized term to replace: period, cycle, phase, stage. See also arm, visit.	Planned interval of time in the conduct of a study wherein an activity is specified and consistent, e.g., specific treatment dose or study activity such as Screening. NOTE: A CDISC variable used in the SDTM model to indicate a time period defined in the protocol with a study-specific purpose. See also arm, visit, phase (within a study).	
2020-12-18	CDISC-4678	Update	C71756	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. Sound 2. Well grounded on principles of evidence. 3. able to withstand criticism or objection. [FDA Glossary of Computerized System and Software Development Terminology]	Well grounded on principles of evidence. [After FDA Glossary of Computerized System and Software Development Terminology]	
2020-12-18	CDISC-4678	Update	C71756	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	Sound	
2020-12-18	CDISC-4678	Update	C753	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A pharmaceutical preparation that does not contain the investigational agent. in blinded studies, it is generally prepared to be physically indistinguishable from the preparation containing the investigational product.	A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.	
2020-12-18	CDISC-4678	Update	C85826	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective.	The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective, secondary objective.	
2020-12-18	CDISC-4678	Update	C85827	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	See objective.	Secondary objectives are supportive or ancillary questions of interest in a trial that will provide further information on the use of the treatment. See also primary objective, objective.	
2020-12-18	CDISC-4678	Update	C93254	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A broad field of medicine that endeavors to create living functional human cells, tissues, and organs to repair or replace tissues or organ function lost due to age, disease, damage, or congenital defects. [After https://www.sciencedirect.com/topics/engineering/regenerative-medicine and http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation.	A broad field of medicine that endeavors to create living functional human cells, tissues, and organs to repair or replace tissues or organ function lost due to age, disease, damage, or congenital defects. [After S.H.Park, et al. In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design. Chapter 12. 2016; https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies] See also regenerative medicine therapy (RMT), regenerative medicine advanced therapy (RMAT) designation, cell therapy, gene therapy.	
2020-12-18	CDISC-4678	Update	C98704	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. [FDA, Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics]	A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. [Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry, FDA] See also master protocol.