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
2023-03-31	CDISC-6006	Add	C198230	Term	Protocol Entity Terminology	Protocol Entity Terminology	Add new term to existing codelist	- - -	Substudy	
2023-03-31	CDISC-6006	Add	C165770	Term	Substudy Attribute Terminology	Substudy Attribute Terminology	Add new term to new codelist	- - -	Master Protocol	
2023-03-31	CDISC-6006	Add	C197998	CDISC Codelist	Substudy Attribute Terminology	Substudy Attribute Terminology	Addition of new codelist	- - -	Substudy Attribute Terminology	
2023-03-31	CDISC-6006	Add	C198229	Term	Substudy Attribute Terminology	Substudy Attribute Terminology	Add new term to new codelist	- - -	Substudy Protocol	
2023-03-31	CDISC-5381	Add	C198366	Term	TPHASE	Trial Phase Response	Add new term to existing codelist	- - -	PHASE I/II/III TRIAL	
2023-03-31	CDISC-5211	Add	C198367	Term	TPHASE	Trial Phase Response	Add new term to existing codelist	- - -	PHASE I/III TRIAL	
2023-03-31	CDISC-5773	Update	C15601	CDISC Definition	TPHASE	Trial Phase Response	Update CDISC Definition	Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b. (CDISC Glossary)	
2023-03-31	CDISC-5773	Update	C15602	CDISC Definition	TPHASE	Trial Phase Response	Update CDISC Definition	Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b. (CDISC Glossary)	
2023-03-31	CDISC-5773	Update	C15603	CDISC Definition	TPHASE	Trial Phase Response	Update CDISC Definition	Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)	Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase. (CDISC Glossary)