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
2023-09-29	CDISC-6178	Add	C164706	Term	Biomarker Attribute Terminology	Biomarker Attribute Terminology	Add new term to new codelist	- - -	Biomarker Name	
2023-09-29	CDISC-6178	Add	C201266	CDISC Codelist	Biomarker Attribute Terminology	Biomarker Attribute Terminology	Addition of new codelist	- - -	Biomarker Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201359	Term	Biomarker Attribute Terminology	Biomarker Attribute Terminology	Add new term to new codelist	- - -	Biomarker Category	
2023-09-29	CDISC-6178	Add	C201267	CDISC Codelist	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Addition of new codelist	- - -	Biomarker Category Value Set Terminology	
2023-09-29	CDISC-6178	Add	C201303	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Response Biomarker	
2023-09-29	CDISC-6178	Add	C201360	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Susceptibility Biomarker	
2023-09-29	CDISC-6178	Add	C201361	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Diagnostic Biomarker	
2023-09-29	CDISC-6178	Add	C201362	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Monitoring Biomarker	
2023-09-29	CDISC-6178	Add	C201363	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Prognostic Biomarker	
2023-09-29	CDISC-6178	Add	C201364	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Predictive Biomarker	
2023-09-29	CDISC-6178	Add	C201365	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Pharmacodynamic Biomarker	
2023-09-29	CDISC-6178	Add	C201366	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Surrogate Endpoint Biomarker	
2023-09-29	CDISC-6178	Add	C201367	Term	Biomarker Category Value Set Terminology	Biomarker Category Value Set Terminology	Add new term to new codelist	- - -	Safety Biomarker	
2023-09-29	CDISC-6178	Add	C16342	Term	Protocol Entity Terminology	Protocol Entity Terminology	Add new term to existing codelist	- - -	Biomarker	
2023-09-29	CDISC-5983	Add	C201484	Term	TTYPE	Trial Type Response	Add new term to existing codelist	- - -	MASS BALANCE	
2023-09-29	CDISC-6178	Update	C20050	CDISC Synonym	Pharmacology Attribute Terminology	Pharmacology Attribute Terminology	Remove CDISC Synonym	Pharmacogenetics	- - -	
2023-09-29	CDISC-6178	Update	C25690	CDISC Definition	Physical Address Attribute Terminology	Physical Address Attribute Terminology	Update CDISC Definition	The street name and building number where an entity is located.	The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located.	
2023-09-29	CDISC-6178	Update	C71104	CDISC Definition	Protocol Entity Terminology	Protocol Entity Terminology	Update CDISC Definition	1) A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). 2) A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.(1. modified from ICH E6 Glossary, Directive 2001/20/EC. 2. NIH revised definition 2015) (CDISC Glossary)	A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] (CDISC Glossary)	
2023-09-29	CDISC-6178	Update	C172457	CDISC Definition	Study Arm Attribute Terminology	Study Arm Attribute Terminology	Update CDISC Definition	The identification of the kind of arm(s) for the study. (NCI)	A characterization or classification of the study arm.	
2023-09-29	CDISC-6178	Update	C142516	CDISC Definition	Study Product Administration Attribute	Study Product Administration Attribute	Update CDISC Definition	The schedule of doses of a therapeutic agent per unit of time, including: the time between doses (e.g., every 6 hours) or the time when the dose(s) are to be given (e.g., at 8 a.m. and 4 p.m. daily), and the amount of a medicine (e.g., number of capsules) to be given at each specific time. (Segen's Medical Dictionary)	The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style]	
2023-09-29	CDISC-6178	Update	C49686	CDISC Definition	TPHASE	Trial Phase Response	Update CDISC Definition	A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI)	Early Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] (CDISC Glossary)	
2023-09-29	CDISC-6178	Update	C49688	CDISC Definition	TPHASE	Trial Phase Response	Update CDISC Definition	A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI)	Later Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.]	
2023-09-29	CDISC-6178	Update	C49689	CDISC Definition	TPHASE	Trial Phase Response	Update CDISC Definition	A subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval.	Later Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. (CDISC Glossary)