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
2022-12-16	CDISC-5899	Add	C71473	Term	Protocol Entity Terminology	Protocol Entity Terminology	Add new term to existing codelist	- - -	Study Activity	
2022-12-16	CDISC-5899	Add	C190866	CDISC Codelist	Study Activity Attribute Terminology	Study Activity Attribute Terminology	Addition of new codelist	- - -	Study Activity Attribute Terminology	
2022-12-16	CDISC-5899	Add	C191214	Term	Study Activity Attribute Terminology	Study Activity Attribute Terminology	Add new term to new codelist	- - -	Study Visit	
2022-12-16	CDISC-5899	Add	C191215	Term	Study Activity Attribute Terminology	Study Activity Attribute Terminology	Add new term to new codelist	- - -	Study Visit Window	
2022-12-16	CDISC-5899	Add	C25217	Term	Study Activity Attribute Terminology	Study Activity Attribute Terminology	Add new term to new codelist	- - -	Study Assessment	
2022-12-16	CDISC-5899	Add	C82437	Term	Study Activity Attribute Terminology	Study Activity Attribute Terminology	Add new term to new codelist	- - -	Study Day	
2022-12-16	CDISC-5899	Update	C139171	CDISC Definition	Clinical Trial Attribute Terminology	Clinical Trial Attribute Terminology	Update CDISC Definition	Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. Compare with study start. [Modified from ICH E3] (CDISC Glossary)	Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] (CDISC Glossary)	
2022-12-16	CDISC-5899	Update	C68772	CDISC Definition	Endpoint Type Value Set Terminology	Endpoint Type Value Set Terminology	Update CDISC Definition	Endpoint(s) used in clinical studies as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint is expected to predict clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself. (After NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/)	An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource)	
2022-12-16	CDISC-5899	Update	C16468	CDISC Definition	Informed Consent Attribute Terminology	Informed Consent Attribute Terminology	Update CDISC Definition	A formal document explaining the potential risks and benefits of participation in a study and the rights and responsibilities of the parties involved, in a manner that is understandable to the subject or their legally authorized representative.	A formal document used during the informed consent process explaining the potential risks and benefits of participation in a study and the rights and responsibilities of the parties involved, in a manner that is understandable to the subject or their legally authorized representative.	
2022-12-16	CDISC-5899	Update	C82533	CDISC Definition	Ingredient Type Value Set Terminology	Ingredient Type Value Set Terminology	Update CDISC Definition	Any component of a study 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))	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))	
2022-12-16	CDISC-5899	Update	C16830	CDISC Definition	INTTYPE	Intervention Type Response	Update CDISC Definition	Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s).	Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices]	
2022-12-16	CDISC-5899	Update	C307	CDISC Definition	INTTYPE	Intervention Type Response	Update CDISC Definition	A substance made from living organisms or things they produce, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product.	A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. (FDA 21 CFR 600.3)	
2022-12-16	CDISC-5899	Update	C70793	CDISC Definition	Protocol Contact Role Value Set	Protocol Contact Role Value Set	Update CDISC Definition	An entity that is responsible for the initiation, management, and/or financing of a clinical study.	An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP]	
2022-12-16	CDISC-5899	Update	C142444	CDISC Definition	Protocol Entity Terminology	Protocol Entity Terminology	Update CDISC Definition	The act of concluding participation, prior to completion of all protocol-required elements, in a study by an enrolled subject. Examples of discontinuation type include: subject withdrawal (active discontinuation by a subject); investigator initiated discontinuation; lost to follow-up (cessation of participation without notice or action by the subject); sponsor initiated discontinuation. (CDISC Glossary)	The act of concluding participation by an enrolled subject prior to completion of all protocol-required elements in a study. NOTE: Four categories of discontinuation are distinguished: a) dropout: Active discontinuation by a subject (also a noun referring to such a discontinued subject); b) investigator initiated discontinuation (e.g., for cause); c) loss to follow-up: cessation of participation without notice or action by the subject; d) sponsor initiated discontinuation. Note that subject discontinuation does not necessarily imply exclusion of subject data from analysis. "Termination of subject" has a history of synonymous use, but is now considered nonstandard. [After ICH E3, section 10.1 and FDA Guidance for Industry: Submission of Abbreviated Reports & Synopses in Support of Marketing Applications, IV A] (CDISC Glossary)	
2022-12-16	CDISC-5899	Update	C142738	CDISC Definition	Protocol Entity Terminology	Protocol Entity Terminology	Update CDISC Definition	The act of enrolling a new study subject to compensate for another subject no longer participating in the study.	The act of enrolling a new study subject to compensate for a subject who is no longer participating.	
2022-12-16	CDISC-5899	Update	C25212	CDISC Definition	Protocol Entity Terminology	Protocol Entity Terminology	Update CDISC Definition	A defined variable intended to reflect an outcome measure of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary)	A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary)	
2022-12-16	CDISC-5899	Update	C25218	CDISC Definition	Protocol Entity Terminology	Protocol Entity Terminology	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. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224] (CDISC-Glossary)	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]	
2022-12-16	CDISC-5899	Update	C49068	CDISC Definition	Study Blinding and Unblinding Attribute Terminology	Study Blinding and Unblinding Attribute Terminology	Update CDISC Definition	A study event during which the treatment assignment is made known to the subject, investigator, and/or other trial personnel.	A procedure to limit bias by preventing subjects and/ or study personnel from identifying which treatments or procedures are administered, or from learning the results of tests and measures undertaken as part of a clinical investigation. (CDISC Glossary)	
2022-12-16	CDISC-5899	Update	C49068	CDISC Synonym	Study Blinding and Unblinding Attribute Terminology	Study Blinding and Unblinding Attribute Terminology	Remove CDISC Synonym	Masking	- - -	
2022-12-16	CDISC-5899	Update	C49068	CDISC Synonym	Study Blinding and Unblinding Attribute Terminology	Study Blinding and Unblinding Attribute Terminology	Remove CDISC Synonym	Study Masking	- - -	
2022-12-16	CDISC-5899	Update	C49068	CDISC Synonym	Study Blinding and Unblinding Attribute Terminology	Study Blinding and Unblinding Attribute Terminology	Remove CDISC Synonym	Trial Masking	- - -	
2022-12-16	CDISC-5899	Update	C115753	CDISC Definition	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Update CDISC Definition	A description of the strategy, methods, responsibilities, and requirements for monitoring the study. (ICH E6(R2))	A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. (ICH E6(R2) Glossary Addendum)	
2022-12-16	CDISC-5899	Update	C142488	CDISC Definition	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Update CDISC Definition	Review of study data for completeness, consistency, and accuracy for the duration of the study lifecycle.	Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle.