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
2019-12-20	CDISC-3808	Add	C103180	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	data standards	
2019-12-20	CDISC-4128	Add	C15538	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	arm (protocol)	C142684 is being removed from the codelist and replaced with C15538
2019-12-20	CDISC-4128	Add	C158128	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	challenge agent	
2019-12-20	CDISC-4128	Add	C15862	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	translational research	
2019-12-20	CDISC-3745	Add	C165770	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	master protocol	
2019-12-20	CDISC-4128	Add	C165822	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	background treatment	
2019-12-20	CDISC-4128	Add	C165823	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	basket protocol	
2019-12-20	CDISC-4128	Add	C165824	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	co-packaged product	
2019-12-20	CDISC-4128	Add	C165825	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	cross-labeled product	
2019-12-20	CDISC-4128	Add	C165826	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	end-point assessment medicinal product	
2019-12-20	CDISC-3614	Add	C165827	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	general observation class	
2019-12-20	CDISC-3808	Add	C165828	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	non-confirmatory result	
2019-12-20	CDISC-4128	Add	C165829	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	platform protocol	
2019-12-20	CDISC-4128	Add	C165830	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	Real-World Data (RWD)	
2019-12-20	CDISC-4128	Add	C165831	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	Real-World Evidence (RWE)	
2019-12-20	CDISC-3735	Add	C165832	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	regenerative medicine advanced therapy (RMAT) designation	
2019-12-20	CDISC-4128	Add	C165833	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	regenerative medicine therapy (RMT)	
2019-12-20	CDISC-4128	Add	C165834	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	remote clinical trial	
2019-12-20	CDISC-4128	Add	C165835	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	rescue medications	
2019-12-20	CDISC-4128	Add	C165836	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	single-entity product	
2019-12-20	CDISC-3900	Add	C165837	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	software as a medical device (SaMD)	
2019-12-20	CDISC-4128	Add	C165838	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	special purpose domain	
2019-12-20	CDISC-3808	Add	C165839	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	Standards Development Organization (SDO)	
2019-12-20	CDISC-3808	Add	C165840	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	Study Data Standardization Plan (SDSP)	
2019-12-20	CDISC-3877	Add	C165841	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	traceability (data)	
2019-12-20	CDISC-4128	Add	C165842	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	umbrella protocol	
2019-12-20	CDISC-4128	Add	C18223	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	therapeutic index	
2019-12-20	CDISC-4128	Add	C19924	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	principal investigator	
2019-12-20	CDISC-3337	Add	C25409	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	administration (substance)	
2019-12-20	CDISC-4128	Add	C53312	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	retrospective study	
2019-12-20	CDISC-4128	Add	C74589	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	event	
2019-12-20	CDISC-3258	Add	C93254	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	regenerative medicine	
2019-12-20	CDISC-3146	Add	C95337	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	active ingredient dose	
2019-12-20	CDISC-4128	Add	C95344	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	product dose	
2019-12-20	CDISC-4128	Remove	C142684	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	arm	- - -	C142684 is being removed from the codelist and replaced with C15538
2019-12-20	CDISC-4128	Remove	C94204	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	data and safety monitoring board (DSMB)	- - -	C94204 is being removed from the codelist and will be merged into C142489. These terms were determined to be synonymous.
2019-12-20	CDISC-3808	Update	C142381	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic.	Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic, semantic interoperability.	
2019-12-20	CDISC-3808	Update	C142383	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out. [After ISO 11615 Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information, Second edition 2017-10]	Pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out. [After ISO 11615 Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information, Second edition 2017-10] See also route of administration, administration (substance).	
2019-12-20	CDISC-3808	Update	C142416	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	CDISC Standard (The)	CDISC standards	
2019-12-20	CDISC-3808	Update	C142416	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	CDISC term for a proposed uniform CDISC standard intended to address the full life-cycle of a clinical trial including protocol representation, capture of source data, submission, and archiving using a set of fully integrated and consistent models, terms, and controlled vocabularies derived from the current set of CDISC standards.	A set of models, implementation guides, controlled vocabularies, and exchange formats developed by the Clinical Data Interchange Standards Consortium (CDISC), which are intended to provide for consistent use of common representations of data, terms and specifications. NOTE: These standards apply to translational research, electronic submission of clinical data, and the life-cycle of clinical product development, which includes protocol representation, data collection, aggregation, tabulation, and analysis and unambiguous information exchange across disparate systems. [After https://www.ncbi.nlm.nih.gov]. See also standard, data standards, Study Data Standardization Plan, and Standards Development Organization.	
2019-12-20	CDISC-3808	Update	C142460	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Phase 3 trial during which the previously revealed actions of a therapeutic intervention are confirmed. NOTE: Procedures in confirmatory trials should be set firmly in advance. Compare to exploratory trial.	Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result. Compare to exploratory trial.	
2019-12-20	CDISC-3808	Update	C142476	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on "GxP data integrity") See also ALCOA, ALCOA+. Compare to data quality.	A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on "GxP data integrity") See also ALCOA, ALCOA+, traceability (data). Compare to data quality.	
2019-12-20	CDISC-3808	Update	C142489	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	DSMB	C94204 is being removed from the codelist and will be merged into C142489. These terms were determined to be synonymous.
2019-12-20	CDISC-3808	Update	C142489	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	Data and Safety Monitoring Board	C94204 is being removed from the codelist and will be merged into C142489. These terms were determined to be synonymous.
2019-12-20	CDISC-3808	Update	C142495	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An individual who is the subject of personal data, persons to whom data refers. [ISO/TS 25237:2008]	In the context of privacy guidelines, An individual who is the subject of personal data, persons to whom data refers, and from whom data are collected, processed, and stored. [after ISO/TS 2537:2008; and EU GDPR] See also study participant, participant.	
2019-12-20	CDISC-3808	Update	C142506	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Table used by XML review tools to configure a review engine to deal with CDISC standard data for a trial.	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]	
2019-12-20	CDISC-3808	Update	C142515	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	XML specification for content and presentation of data and text in a document including definitions for the elements considered to be legal in the document. NOTE: Agreeing on a common DTD facilitates interoperability among systems incorporating the agreed standards. [from XML files.com]	XML specification for content and presentation of data and text in a document including definitions for the elements considered to be legal in the document. NOTE: Agreeing on a common DTD facilitates interoperability among systems incorporating the agreed standards. [From Electronic Submission File Formats and Specifications. Orientation and Best Practices For Data Formats and Submission to The Center For Tobacco Products. January 2018; Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry. January 2019]	
2019-12-20	CDISC-3808	Update	C142517	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	dosage strength	dose strength	
2019-12-20	CDISC-3808	Update	C142517	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. Proportion of active substance to excipient, measured in units of volume or concentration. NOTE: The strength of a drug product tells how much of the active ingredient is present in each dosage. [NOTE: FDA Glossary of Terms]	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]	
2019-12-20	CDISC-3808	Update	C142517	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Dosage Strength	dose strength	
2019-12-20	CDISC-3808	Update	C142587	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. NOTE: CDISC includes test articles in its definition of investigational products. Compare to Investigational Medicinal Product (IMP) from EU-CTR (EU) No 536/2014. [ICH]	A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. NOTE: CDISC includes test articles in its definition of investigational products. Compare to authorised investigational medicinal product from EU-CTR (EU) No 536/2014. [ICH]	
2019-12-20	CDISC-3808	Update	C142591	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An expression meaning the investigator and/or institution, where required by the applicable regulatory requirements. [ICH E6 1.35]	An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements" with respect to the transfer or assignment of responsibilities. [After ICH E6 1.35] See also coordinating investigator, investigator, principal investigator, site investigator, sponsor-investigator, sub-investigator.	
2019-12-20	CDISC-3808	Update	C142646	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol.	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.	
2019-12-20	CDISC-3808	Update	C142695	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH]	An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator, investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.	
2019-12-20	CDISC-3808	Update	C142703	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature)]. [After ICH E10]	In a trial, a comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol).	
2019-12-20	CDISC-3808	Update	C142703	CDISC Synonym	CDISC Glossary	CDISC Glossary	Remove CDISC Synonym	comparator	- - -	
2019-12-20	CDISC-3808	Update	C142710	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A member of the clinical study population from who 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, human subject, data subject, clinical research subject, participant.	
2019-12-20	CDISC-3808	Update	C142747	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [ICH]	Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [ICH E6] See also human subject, patient,  human subject, data subject, clinical research subject, participant, study participant.	
2019-12-20	CDISC-3808	Update	C156629	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Other adverse events that are not study endpoints and are not "expected" (i.e., because they are not in the investigator's brochure) that 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]	Other adverse events that are not study endpoints and are not "expected" (i.e., because they are not in the investigator's brochure) that can be anticipated to occur with some frequency during the course of the trial, regardless of drug exposure, depending on the patient population and disease under study. NOTE: Examples of such "anticipated" events include known consequences of the underlying disease or condition under investigation, events anticipated from any background regimen, or re-emergence or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies]	
2019-12-20	CDISC-3808	Update	C156779	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A person or entity with a role in a clinical study. NOTE: 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.	A person or entity with a role in a clinical study. NOTE: Participants can be human subjects or study personnel. The term "participant" is used with growing frequency in some clinical and patient-facing documents like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, study participant.	
2019-12-20	CDISC-3808	Update	C16960	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Person under a physician's care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. See also subject, trial subject, healthy volunteer. Although often used interchangeably as a synonym for subject, a healthy volunteer is not a patient.	Person under a physician's care for a particular disease or condition. NOTE: A subject in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a subject. Although often used interchangeably as a synonym for subject, a healthy volunteer is not a patient. See also human subject, clinical research subject, healthy volunteer, participant.	
2019-12-20	CDISC-3808	Update	C17237	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	Food and Drug administration (FDA)	Food and Drug Administration (FDA)	
2019-12-20	CDISC-3808	Update	C17237	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The United states regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.	The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.	
2019-12-20	CDISC-3808	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.	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.	
2019-12-20	CDISC-3808	Update	C25936	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team). [21 CFR 50.3] See also sponsor-investigator, site investigator.	An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team). [21 CFR 50.3] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator.	
2019-12-20	CDISC-3808	Update	C28143	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	The group of subjects in a controlled study that receives no treatment, a standard treatment, or a placebo. [21 CFR 314.126] See also controls.	The group of subjects in a controlled study that receives, for example, no treatment, a standard treatment, or a placebo. [21 CFR 314.126] See also control, controlled study, arm (protocol).	
2019-12-20	CDISC-3808	Update	C28279	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A study in which a test article is compared with a treatment that has known effects. The control group may receive no treatment, active treatment, placebo, or dose comparison concurrent control. NOTE: For further information on "adequate and well-controlled study" see 21 CFR 314.126.	A study in which a test article is compared with a treatment that has known effects (active control), no treatment, placebo, or dose comparison concurrent control, or external (historic) control. [21 CFR 314.126 and ICH E10]. See also control, comparator (product), control group.	
2019-12-20	CDISC-3808	Update	C3367	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.	A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event.	
2019-12-20	CDISC-3808	Update	C38114	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Path by which the pharmaceutical product is taken into or makes contact with the body. [After ISO 11615:2017, 3.1.76]	Path by which the pharmaceutical product is taken into or makes contact with the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form.	
2019-12-20	CDISC-3808	Update	C49651	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A healthy person volunteering to participate as a subject in a clinical trial, often a healthy person agreeing to participate in a Phase 1 trial. See also Phase 1.	A healthy person volunteering to participate as a subject in a clinical study.  NOTE: This is often a healthy person agreeing to participate in a Phase 1 trial. See also Phase 1.	
2019-12-20	CDISC-3808	Update	C51818	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. [ICH E6]	An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. NOTE: Depending on the scope of the trial, coordination could be across centers/sites in a region, across regions, or within a nation. [ICH E6] See also investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.	
2019-12-20	CDISC-3808	Update	C51873	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A person responsible for the conduct of the clinical trial at a trial site. if a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [ICH E6 1.35. 2.] See also investigator.	A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. [ICH E6 1.35. 2.] See also investigator, coordinating investigator, investigator/institution, principal investigator, sponsor-investigator, sub-investigator.	
2019-12-20	CDISC-3808	Update	C54622	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [ICH] See also investigator.	Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.	
2019-12-20	CDISC-3808	Update	C54696	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit. 3. A product that is packaged separately but is used only with another product. [Modified from SPL Glossary]	A product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another and are referred to as "constituent parts" of the combination product). NOTE: A combination product might be a single-entity product, a co-packaged product or a cross-labeled product. [After 21 CFR 3.2 (e)] See also single-entity product, co-packaged product, cross-labeled product.	
2019-12-20	CDISC-3808	Update	C62289	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A collection of observations with a topic-specific commonality about each subject in a clinical investigation. NOTE: CDISC classifies domains. For example, the Interventions 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). The Events 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"). The Findings 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.	A collection of logically related observations with a common, specific topic that are normally collected for all subjects in a clinical investigation. NOTE: The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Example domains include laboratory test results (LB), adverse events (AE), concomitant medications (CM). [After SDTM Implementation Guide version 3.2, CDISC.org] See also general observation class.	
2019-12-20	CDISC-3808	Update	C70665	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3].	Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3].  See also clinical research subject.	
2019-12-20	CDISC-3808	Update	C70668	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A person who is enrolled into a clinical study or trial. See also study and trial.	A person who is enrolled into a clinical study or trial. See also study, trial, and study population.	
2019-12-20	CDISC-3808	Update	C70668	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Clinical Trial Subject	Clinical Study Subject	
2019-12-20	CDISC-3808	Update	C70833	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Persons enrolled in a study who meet the inclusion/exclusion criteria as specified in the study protocol.	A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. (CDISC Protocol Entities)	
2019-12-20	CDISC-3808	Update	C81893	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Criterion or specification established by authority or consensus for 1. measuring performance or quality; 2. specifying conventions that support interchange of common materials and information. NOTE: CDISC standards exist to support the exchange of clinical data, for example, at both the syntactic and semantic levels. See interoperability.	A repeatable written norm, pattern, or model that is generally accepted by agreement, established or approved by an authority, or widely accepted and used by custom. [After https://dictionary.cambridge.org/us/dictionary/english/standard, https://www.fda.gov/media/124694/download]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.	
2019-12-20	CDISC-3808	Update	C81893	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	technical standard	
2019-12-20	CDISC-4128	Update	C82533	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Any component of a drug product 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 body of humans or other animals. [Segen's Medical Dictionary]	An active ingredient is any component of a drug product intended to exert pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [After 21 CFR 210.3(b)(7)]	
2019-12-20	CDISC-3804	Update	C94236	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	good clinical practice (GCP)	Good Clinical Practice (GCP)