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	C157352	Term	CNTMODE	Mode of Subject Contact	Add new term to existing codelist	- - -	TEXT MESSAGE	
2023-09-29	CDISC-5942	Add	C25170	Term	CNTMODE	Mode of Subject Contact	Add new term to existing codelist	- - -	E-MAIL	
2023-09-29	CDISC-5943	Add	C70805	Term	CNTMODE	Mode of Subject Contact	Add new term to existing codelist	- - -	LETTER	
2023-09-29	CDISC-6178	Add	C201307	Term	DDF Activity Attribute Terminology	DDF Activity Attribute Terminology	Add new term to existing codelist	- - -	Study Activity is Conditional	
2023-09-29	CDISC-6178	Add	C201308	Term	DDF Activity Attribute Terminology	DDF Activity Attribute Terminology	Add new term to existing codelist	- - -	Study Activity is Conditional Reason	
2023-09-29	CDISC-6178	Add	C201309	Term	DDF Activity Attribute Terminology	DDF Activity Attribute Terminology	Add new term to existing codelist	- - -	Study Activity is Optional	
2023-09-29	CDISC-6178	Add	C201310	Term	DDF Activity Attribute Terminology	DDF Activity Attribute Terminology	Add new term to existing codelist	- - -	Study Activity is Optional Reason	
2023-09-29	CDISC-6178	Add	C176229	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	District	
2023-09-29	CDISC-6178	Add	C201253	CDISC Codelist	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Addition of new codelist	- - -	DDF Address Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201311	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	Address Full Text	
2023-09-29	CDISC-6178	Add	C25160	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	City	
2023-09-29	CDISC-6178	Add	C25464	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	Country	
2023-09-29	CDISC-6178	Add	C25621	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	Postal Code	
2023-09-29	CDISC-6178	Add	C25690	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	Address Line	
2023-09-29	CDISC-6178	Add	C87194	Term	DDF Address Attribute Terminology	DDF Address Attribute Terminology	Add new term to new codelist	- - -	State	
2023-09-29	CDISC-6178	Add	C201254	CDISC Codelist	DDF Biomedical Concept Attribute Terminology	DDF Biomedical Concept Attribute Terminology	Addition of new codelist	- - -	DDF Biomedical Concept Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201312	Term	DDF Biomedical Concept Attribute Terminology	DDF Biomedical Concept Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Name	
2023-09-29	CDISC-6178	Add	C201313	Term	DDF Biomedical Concept Attribute Terminology	DDF Biomedical Concept Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Reference	
2023-09-29	CDISC-6178	Add	C201314	Term	DDF Biomedical Concept Attribute Terminology	DDF Biomedical Concept Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Synonym	
2023-09-29	CDISC-6178	Add	C201255	CDISC Codelist	DDF Biomedical Concept Category Attribute Terminology	DDF Biomedical Concept Category Attribute Terminology	Addition of new codelist	- - -	DDF Biomedical Concept Category Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201315	Term	DDF Biomedical Concept Category Attribute Terminology	DDF Biomedical Concept Category Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Category Code	
2023-09-29	CDISC-6178	Add	C201316	Term	DDF Biomedical Concept Category Attribute Terminology	DDF Biomedical Concept Category Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Category Description	
2023-09-29	CDISC-6178	Add	C201317	Term	DDF Biomedical Concept Category Attribute Terminology	DDF Biomedical Concept Category Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Category Name	
2023-09-29	CDISC-6178	Add	C201256	CDISC Codelist	DDF Biomedical Concept Property Attribute Terminology	DDF Biomedical Concept Property Attribute Terminology	Addition of new codelist	- - -	DDF Biomedical Concept Property Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201318	Term	DDF Biomedical Concept Property Attribute Terminology	DDF Biomedical Concept Property Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Property Concept Code	
2023-09-29	CDISC-6178	Add	C201319	Term	DDF Biomedical Concept Property Attribute Terminology	DDF Biomedical Concept Property Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Property Response Data Type	
2023-09-29	CDISC-6178	Add	C201257	CDISC Codelist	DDF Biomedical Concept Surrogate Attribute Terminology	DDF Biomedical Concept Surrogate Attribute Terminology	Addition of new codelist	- - -	DDF Biomedical Concept Surrogate Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201320	Term	DDF Biomedical Concept Surrogate Attribute Terminology	DDF Biomedical Concept Surrogate Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Surrogate Description	
2023-09-29	CDISC-6178	Add	C201321	Term	DDF Biomedical Concept Surrogate Attribute Terminology	DDF Biomedical Concept Surrogate Attribute Terminology	Add new term to new codelist	- - -	Biomedical Concept Surrogate Reference	
2023-09-29	CDISC-6178	Add	C201322	Term	DDF Clinical Study Attribute Terminology	DDF Clinical Study Attribute Terminology	Add new term to existing codelist	- - -	Business Therapeutic Areas	
2023-09-29	CDISC-6178	Add	C94108	Term	DDF Clinical Study Attribute Terminology	DDF Clinical Study Attribute Terminology	Add new term to existing codelist	- - -	Study Acronym	
2023-09-29	CDISC-6178	Add	C94122	Term	DDF Clinical Study Attribute Terminology	DDF Clinical Study Attribute Terminology	Add new term to existing codelist	- - -	Study Rationale	
2023-09-29	CDISC-6178	Add	C201299	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Scheduled Instance	
2023-09-29	CDISC-6178	Add	C201344	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Alias Code	
2023-09-29	CDISC-6178	Add	C201345	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Biomedical Concept	
2023-09-29	CDISC-6178	Add	C201346	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Biomedical Concept Category	
2023-09-29	CDISC-6178	Add	C201347	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Response Code	
2023-09-29	CDISC-6178	Add	C201348	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Schedule Timeline	
2023-09-29	CDISC-6178	Add	C201349	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Schedule Timeline Exit	
2023-09-29	CDISC-6178	Add	C201350	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Scheduled Activity Instance	
2023-09-29	CDISC-6178	Add	C201351	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Scheduled Decision Instance	
2023-09-29	CDISC-6178	Add	C25407	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Address	
2023-09-29	CDISC-6178	Add	C80484	Term	DDF Entity Terminology	DDF Entity Terminology	Add new term to existing codelist	- - -	Timing	
2023-09-29	CDISC-6178	Add	C201323	Term	DDF Estimand Attribute Terminology	DDF Estimand Attribute Terminology	Add new term to existing codelist	- - -	Variable of Interest	
2023-09-29	CDISC-6178	Add	C201324	Term	DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology	Add new term to existing codelist	- - -	Procedure Description	
2023-09-29	CDISC-6178	Add	C201325	Term	DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology	Add new term to existing codelist	- - -	Procedure Name	
2023-09-29	CDISC-6178	Add	C201326	Term	DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology	Add new term to existing codelist	- - -	Study Procedure is Conditional	
2023-09-29	CDISC-6178	Add	C201327	Term	DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology	Add new term to existing codelist	- - -	Study Procedure is Conditional Reason	
2023-09-29	CDISC-6178	Add	C201328	Term	DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology	Add new term to existing codelist	- - -	Study Procedure is Optional	
2023-09-29	CDISC-6178	Add	C201329	Term	DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology	Add new term to existing codelist	- - -	Study Procedure is Optional Reason	
2023-09-29	CDISC-6178	Add	C201258	CDISC Codelist	DDF Response Code Attribute Terminology	DDF Response Code Attribute Terminology	Addition of new codelist	- - -	DDF Response Code Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201330	Term	DDF Response Code Attribute Terminology	DDF Response Code Attribute Terminology	Add new term to new codelist	- - -	Response Code Enabled Indicator	
2023-09-29	CDISC-6178	Add	C25162	Term	DDF Response Code Attribute Terminology	DDF Response Code Attribute Terminology	Add new term to new codelist	- - -	Code	
2023-09-29	CDISC-6178	Add	C201259	CDISC Codelist	DDF Schedule Timeline Attribute Terminology	DDF Schedule Timeline Attribute Terminology	Addition of new codelist	- - -	DDF Schedule Timeline Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201331	Term	DDF Schedule Timeline Attribute Terminology	DDF Schedule Timeline Attribute Terminology	Add new term to new codelist	- - -	Main Timeline Indicator	
2023-09-29	CDISC-6178	Add	C201332	Term	DDF Schedule Timeline Attribute Terminology	DDF Schedule Timeline Attribute Terminology	Add new term to new codelist	- - -	Schedule Timeline Description	
2023-09-29	CDISC-6178	Add	C201333	Term	DDF Schedule Timeline Attribute Terminology	DDF Schedule Timeline Attribute Terminology	Add new term to new codelist	- - -	Schedule Timeline Entry Condition	
2023-09-29	CDISC-6178	Add	C201334	Term	DDF Schedule Timeline Attribute Terminology	DDF Schedule Timeline Attribute Terminology	Add new term to new codelist	- - -	Schedule Timeline Name	
2023-09-29	CDISC-6178	Add	C201260	CDISC Codelist	DDF Scheduled Decision Instance Attribute Terminology	DDF Scheduled Decision Instance Attribute Terminology	Addition of new codelist	- - -	DDF Scheduled Decision Instance Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201335	Term	DDF Scheduled Decision Instance Attribute Terminology	DDF Scheduled Decision Instance Attribute Terminology	Add new term to new codelist	- - -	Condition Assignments	
2023-09-29	CDISC-6178	Add	C201261	CDISC Codelist	DDF Scheduled Instance Attribute Terminology	DDF Scheduled Instance Attribute Terminology	Addition of new codelist	- - -	DDF Scheduled Instance Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201336	Term	DDF Scheduled Instance Attribute Terminology	DDF Scheduled Instance Attribute Terminology	Add new term to new codelist	- - -	Schedule Sequence Number	
2023-09-29	CDISC-6178	Add	C201337	Term	DDF Scheduled Instance Attribute Terminology	DDF Scheduled Instance Attribute Terminology	Add new term to new codelist	- - -	Scheduled Instance Type	
2023-09-29	CDISC-6178	Add	C172457	Term	DDF Study Arm Attribute Terminology	DDF Study Arm Attribute Terminology	Add new term to existing codelist	- - -	Study Arm Type	C188827 is being removed from the codelist and being replaced with C172457.
2023-09-29	CDISC-6178	Add	C101302	Term	DDF Study Design Attribute Terminology	DDF Study Design Attribute Terminology	Add new term to existing codelist	- - -	Therapeutic Areas	
2023-09-29	CDISC-6178	Add	C142705	Term	DDF Study Design Attribute Terminology	DDF Study Design Attribute Terminology	Add new term to existing codelist	- - -	Study Design Rationale	
2023-09-29	CDISC-6178	Add	C147139	Term	DDF Study Design Attribute Terminology	DDF Study Design Attribute Terminology	Add new term to existing codelist	- - -	Study Design Description	
2023-09-29	CDISC-6178	Add	C201338	Term	DDF Study Design Attribute Terminology	DDF Study Design Attribute Terminology	Add new term to existing codelist	- - -	Study Design Name	
2023-09-29	CDISC-6178	Add	C49658	Term	DDF Study Design Attribute Terminology	DDF Study Design Attribute Terminology	Add new term to existing codelist	- - -	Trial Blinding Schema	
2023-09-29	CDISC-6178	Add	C49692	Term	DDF Study Design Population Attribute Terminology	DDF Study Design Population Attribute Terminology	Add new term to existing codelist	- - -	Planned Number of Participants	
2023-09-29	CDISC-6178	Add	C49693	Term	DDF Study Design Population Attribute Terminology	DDF Study Design Population Attribute Terminology	Add new term to existing codelist	- - -	Planned Minimum Age of Subjects	
2023-09-29	CDISC-6178	Add	C49694	Term	DDF Study Design Population Attribute Terminology	DDF Study Design Population Attribute Terminology	Add new term to existing codelist	- - -	Planned Maximum Age of Subjects	
2023-09-29	CDISC-6178	Add	C49696	Term	DDF Study Design Population Attribute Terminology	DDF Study Design Population Attribute Terminology	Add new term to existing codelist	- - -	Sex of Participants	
2023-09-29	CDISC-6178	Add	C201339	Term	DDF Study Element Attribute Terminology	DDF Study Element Attribute Terminology	Add new term to existing codelist	- - -	Transition End Rule	
2023-09-29	CDISC-6178	Add	C201340	Term	DDF Study Element Attribute Terminology	DDF Study Element Attribute Terminology	Add new term to existing codelist	- - -	Transition Start Rule	
2023-09-29	CDISC-6178	Add	C164648	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Description	
2023-09-29	CDISC-6178	Add	C201262	CDISC Codelist	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Addition of new codelist	- - -	DDF Timing Attribute Terminology	
2023-09-29	CDISC-6178	Add	C201297	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Relative To From	
2023-09-29	CDISC-6178	Add	C201298	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Type	
2023-09-29	CDISC-6178	Add	C201341	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Value	
2023-09-29	CDISC-6178	Add	C201342	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Window, Lower	
2023-09-29	CDISC-6178	Add	C201343	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Window, Upper	
2023-09-29	CDISC-6178	Add	C48921	Term	DDF Timing Attribute Terminology	DDF Timing Attribute Terminology	Add new term to new codelist	- - -	Timing Window	
2023-09-29	CDISC-6178	Add	C16576	Term	SEXPOP	Sex of Participants Response	Add new term to new codelist	- - -	F	
2023-09-29	CDISC-6178	Add	C20197	Term	SEXPOP	Sex of Participants Response	Add new term to new codelist	- - -	M	
2023-09-29	CDISC-6178	Add	C49636	Term	SEXPOP	Sex of Participants Response	Add new term to new codelist	- - -	BOTH	
2023-09-29	CDISC-6178	Add	C66732	CDISC Codelist	SEXPOP	Sex of Participants Response	Addition of new codelist	- - -	SEXPOP	
2023-09-29	CDISC-6178	Add	C15538	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Treatment Arm	
2023-09-29	CDISC-6178	Add	C174222	CDISC Codelist	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Addition of new codelist	- - -	Study Arm Type Value Set Terminology	
2023-09-29	CDISC-6178	Add	C174226	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Control Arm	
2023-09-29	CDISC-6178	Add	C174266	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Experimental Arm	
2023-09-29	CDISC-6178	Add	C174267	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Active Comparator Arm	
2023-09-29	CDISC-6178	Add	C174268	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Placebo Comparator Arm	
2023-09-29	CDISC-6178	Add	C174269	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Sham Comparator Arm	
2023-09-29	CDISC-6178	Add	C174270	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	No Intervention Arm	
2023-09-29	CDISC-6178	Add	C15228	Term	TBLIND	Trial Blinding Schema Response	Add new term to new codelist	- - -	DOUBLE BLIND	
2023-09-29	CDISC-6178	Add	C156592	Term	TBLIND	Trial Blinding Schema Response	Add new term to new codelist	- - -	OPEN LABEL TO TREATMENT AND DOUBLE BLIND TO IMP DOSE	
2023-09-29	CDISC-6178	Add	C187674	Term	TBLIND	Trial Blinding Schema Response	Add new term to new codelist	- - -	OBSERVER BLIND	
2023-09-29	CDISC-6178	Add	C28233	Term	TBLIND	Trial Blinding Schema Response	Add new term to new codelist	- - -	SINGLE BLIND	
2023-09-29	CDISC-6178	Add	C49659	Term	TBLIND	Trial Blinding Schema Response	Add new term to new codelist	- - -	OPEN LABEL	
2023-09-29	CDISC-6178	Add	C66735	CDISC Codelist	TBLIND	Trial Blinding Schema Response	Addition of new codelist	- - -	TBLIND	
2023-09-29	CDISC-6178	Add	C201265	CDISC Codelist	Timing Relative To From Value Set Terminology	Timing Relative To From Value Set Terminology	Addition of new codelist	- - -	Timing Relative To From Value Set Terminology	
2023-09-29	CDISC-6178	Add	C201352	Term	Timing Relative To From Value Set Terminology	Timing Relative To From Value Set Terminology	Add new term to new codelist	- - -	End to End	
2023-09-29	CDISC-6178	Add	C201353	Term	Timing Relative To From Value Set Terminology	Timing Relative To From Value Set Terminology	Add new term to new codelist	- - -	End to Start	
2023-09-29	CDISC-6178	Add	C201354	Term	Timing Relative To From Value Set Terminology	Timing Relative To From Value Set Terminology	Add new term to new codelist	- - -	Start to End	
2023-09-29	CDISC-6178	Add	C201355	Term	Timing Relative To From Value Set Terminology	Timing Relative To From Value Set Terminology	Add new term to new codelist	- - -	Start to Start	
2023-09-29	CDISC-6178	Add	C201264	CDISC Codelist	Timing Type Value Set Terminology	Timing Type Value Set Terminology	Addition of new codelist	- - -	Timing Type Value Set Terminology	
2023-09-29	CDISC-6178	Add	C201356	Term	Timing Type Value Set Terminology	Timing Type Value Set Terminology	Add new term to new codelist	- - -	After	
2023-09-29	CDISC-6178	Add	C201357	Term	Timing Type Value Set Terminology	Timing Type Value Set Terminology	Add new term to new codelist	- - -	Before	
2023-09-29	CDISC-6178	Add	C201358	Term	Timing Type Value Set Terminology	Timing Type Value Set Terminology	Add new term to new codelist	- - -	Fixed Reference	
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	Remove	C188843	Term	DDF Activity Attribute Terminology	DDF Activity Attribute Terminology	Remove term entirely from codelist	Previous Activity Identifier	- - -	Remove from codelist. Attribute changing to Relationship in USDM Model.
2023-09-29	CDISC-6178	Remove	C188844	Term	DDF Activity Attribute Terminology	DDF Activity Attribute Terminology	Remove term entirely from codelist	Next Activity Identifier	- - -	Remove from codelist. Attribute changing to Relationship in USDM Model.
2023-09-29	CDISC-6178	Remove	C188811	Term	DDF Entity Terminology	DDF Entity Terminology	Remove term entirely from codelist	Clinical Study Data	- - -	Retire entity from DDF USDM Model
2023-09-29	CDISC-6178	Remove	C188812	Term	DDF Entity Terminology	DDF Entity Terminology	Remove term entirely from codelist	Workflow Item Description	- - -	Retire entity from DDF USDM Model
2023-09-29	CDISC-6178	Remove	C42753	Term	DDF Entity Terminology	DDF Entity Terminology	Remove term entirely from codelist	Workflow	- - -	Retire entity from DDF USDM Model
2023-09-29	CDISC-6178	Remove	C188827	Term	DDF Study Arm Attribute Terminology	DDF Study Arm Attribute Terminology	Remove term entirely from codelist	Study Arm Type Name	- - -	C188827 is being removed from the codelist and being replaced with C172457.
2023-09-29	CDISC-6178	Remove	C188715	CDISC Codelist	DDF Study Data Attribute Terminology	DDF Study Data Attribute Terminology	Retire codelist	DDF Study Data Attribute Terminology	- - -	Remove codelist C188715 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188845	Term	DDF Study Data Attribute Terminology	DDF Study Data Attribute Terminology	Remove term from retired codelist	Clinical Study Data Name	- - -	Remove codelist C188715 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188846	Term	DDF Study Data Attribute Terminology	DDF Study Data Attribute Terminology	Remove term from retired codelist	Clinical Study Data Description	- - -	Remove codelist C188715 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188847	Term	DDF Study Data Attribute Terminology	DDF Study Data Attribute Terminology	Remove term from retired codelist	Electronic Case Report Form Link	- - -	Remove codelist C188715 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188717	CDISC Codelist	DDF Workflow Attribute Terminology	DDF Workflow Attribute Terminology	Retire codelist	DDF Workflow Attribute Terminology	- - -	Remove codelist C188717 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188849	Term	DDF Workflow Attribute Terminology	DDF Workflow Attribute Terminology	Remove term from retired codelist	Workflow Description	- - -	Remove codelist C188717 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188718	CDISC Codelist	DDF Workflow Item Attribute Terminology	DDF Workflow Item Attribute Terminology	Retire codelist	DDF Workflow Item Attribute Terminology	- - -	Remove codelist C188718 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188812	Term	DDF Workflow Item Attribute Terminology	DDF Workflow Item Attribute Terminology	Remove term from retired codelist	Workflow Item Description	- - -	Remove codelist C188718 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188851	Term	DDF Workflow Item Attribute Terminology	DDF Workflow Item Attribute Terminology	Remove term from retired codelist	Previous Workflow Item Identifier	- - -	Remove codelist C188718 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Remove	C188852	Term	DDF Workflow Item Attribute Terminology	DDF Workflow Item Attribute Terminology	Remove term from retired codelist	Next Workflow Item Identifier	- - -	Remove codelist C188718 and its valid values from DDF. The Model has changed as part of Phase 2 and this codelist is no longer required.
2023-09-29	CDISC-6178	Update	C188823	CDISC Definition	DDF Objective Attribute Terminology	DDF Objective Attribute Terminology	Update CDISC Definition	A characterization or classification of the study endpoint that determines its category of importance relative to other study objectives.	A characterization or classification of the study objective that determines its category of importance relative to other study objectives.	
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)