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
2019-09-27	CDISC-4027	Update	C93682	CDISC Definition	Clinical Study Attribute Terminology	Clinical Study Attribute Terminology	Update CDISC Definition	A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a subject could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments.	A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments.	
2019-09-27	CDISC-4027	Update	C139170	CDISC Definition	Clinical Trial Attribute Terminology	Clinical Trial Attribute Terminology	Update CDISC Definition	The country in which subjects are located when enrolling in a trial or study. (NCI)	The country in which participants are located when enrolling in a trial or study.	
2019-09-27	CDISC-4027	Update	C147068	CDISC Codelist Name	Participant Allocation Response	Participant Allocation Response	Update CDISC Codelist Name	Subject Allocation Response	Participant Allocation Response	
2019-09-27	CDISC-4027	Update	C147068	CDISC Submission Value	Participant Allocation Response	Participant Allocation Response	Update CDISC Submission Value	Subject Allocation Response	Participant Allocation Response	
2019-09-27	CDISC-4027	Update	C147068	CDISC Definition	Participant Allocation Response	Participant Allocation Response	Update CDISC Definition	A terminology codelist for the method of assigning subjects to groups or categories within a clinical study.	A terminology codelist for the method of assigning participants, or subjects, to groups or categories within a clinical study.	
2019-09-27	CDISC-4027	Update	C147068	CDISC Synonym	Participant Allocation Response	Participant Allocation Response	Add new CDISC Synonym	- - -	Participant Allocation Response	
2019-09-27	CDISC-4027	Update	C147068	CDISC Synonym	Participant Allocation Response	Participant Allocation Response	Remove CDISC Synonym	Subject Allocation Response	- - -	
2019-09-27	CDISC-4027	Update	C25196	CDISC Codelist Name	Participant Allocation Response	Participant Allocation Response	Update CDISC Codelist Name	Subject Allocation Response	Participant Allocation Response	
2019-09-27	CDISC-4027	Update	C48660	CDISC Codelist Name	Participant Allocation Response	Participant Allocation Response	Update CDISC Codelist Name	Subject Allocation Response	Participant Allocation Response	
2019-09-27	CDISC-4027	Update	C93043	CDISC Codelist Name	Participant Allocation Response	Participant Allocation Response	Update CDISC Codelist Name	Subject Allocation Response	Participant Allocation Response	
2019-09-27	CDISC-4027	Add	C142707	Term	Protocol Entity Terminology	Protocol Entity Terminology	Add new term to existing codelist	- - -	Study Monitoring	
2019-09-27	CDISC-4027	Update	C142743	CDISC Definition	Randomization Type Response	Randomization Type Response	Update CDISC Definition	A type of randomization schema in which unequal numbers of subjects are purposely assigned to multiple treatment groups.	A type of randomization schema in which unequal numbers of participants are purposely assigned to multiple treatment groups.	
2019-09-27	CDISC-4027	Update	C147126	CDISC Definition	Randomization Type Response	Randomization Type Response	Update CDISC Definition	A type of randomization schema in which the group assignment probability of a subject is adjusted based on the group assignments of those subjects already randomized in the trial. (NCI)	A type of randomization schema in which the group assignment probability of a participant is adjusted based on the group assignments of those participants already randomized in the trial.	
2019-09-27	CDISC-4027	Update	C147127	CDISC Definition	Randomization Type Response	Randomization Type Response	Update CDISC Definition	A type of adaptive randomization in which a pre-specified number of subjects is assigned to a block containing the same pre-specified number of balanced group assignments in random order.	A type of adaptive randomization in which a pre-specified number of participants is assigned to a block containing the same pre-specified number of balanced group assignments in random order.	
2019-09-27	CDISC-4027	Update	C147143	CDISC Definition	Randomization Type Response	Randomization Type Response	Update CDISC Definition	A type of adaptive randomization in which the subject is assigned to the treatment group in an attempt to minimize imbalances in the number of subjects for each stratification covariate across treatment groups.	A type of adaptive randomization in which the participant is assigned to the treatment group in an attempt to minimize imbalances in the number of participants for each stratification covariate across treatment groups.	
2019-09-27	CDISC-4027	Update	C147144	CDISC Definition	Randomization Type Response	Randomization Type Response	Update CDISC Definition	A type of randomization schema in which each subject has the same chance of being randomized into any one group as all other subjects. (NCI)	A type of randomization schema in which each participant has the same chance of being randomized into any one group as all other participants.	
2019-09-27	CDISC-4027	Update	C147145	CDISC Definition	Randomization Type Response	Randomization Type Response	Update CDISC Definition	A type of block randomization in which subjects are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. (NCI)	A type of block randomization in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups.	
2019-09-27	CDISC-4027	Update	C147140	CDISC Definition	Study Design Attribute Terminology	Study Design Attribute Terminology	Update CDISC Definition	The type of randomization method used to assign subjects to treatment groups or cohorts. (NCI)	The type of randomization method used to assign particpants to treatment groups or cohorts.	
2019-09-27	CDISC-4027	Update	C49692	CDISC Submission Value	Study Design Attribute Terminology	Study Design Attribute Terminology	Update CDISC Submission Value	Planned Number of Subjects	Planned Number of Participants	
2019-09-27	CDISC-4027	Update	C52580	CDISC Submission Value	Study Design Attribute Terminology	Study Design Attribute Terminology	Update CDISC Submission Value	Subject Allocation	Participant Allocation	
2019-09-27	CDISC-4027	Update	C52580	CDISC Definition	Study Design Attribute Terminology	Study Design Attribute Terminology	Update CDISC Definition	The process of assigning subjects to particular treatment groups or cohorts in a clinical study.	The process of assigning participants to particular treatment groups or cohorts in a clinical study.	
2019-09-27	CDISC-4027	Update	C52580	CDISC Synonym	Study Design Attribute Terminology	Study Design Attribute Terminology	Add new CDISC Synonym	- - -	Subject Allocation	
2019-09-27	CDISC-4027	Add	C115753	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Clinical Monitoring Plan	
2019-09-27	CDISC-4027	Add	C142488	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Data Monitoring	
2019-09-27	CDISC-4027	Add	C142674	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Risk Monitoring	
2019-09-27	CDISC-4027	Add	C15789	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Trial Monitoring	
2019-09-27	CDISC-4027	Add	C163026	CDISC Codelist	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Addition of new codelist	- - -	Study Monitoring Attribute Terminology	
2019-09-27	CDISC-4027	Add	C163406	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Data and Safety Monitoring Plan	
2019-09-27	CDISC-4027	Add	C163407	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	GCP Adherence Statement	
2019-09-27	CDISC-4027	Add	C163408	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Safety Data Monitoring	
2019-09-27	CDISC-4027	Add	C163409	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Safety Monitoring	
2019-09-27	CDISC-4027	Add	C163410	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Study Monitoring Statement	
2019-09-27	CDISC-4027	Add	C163411	Term	Study Monitoring Attribute Terminology	Study Monitoring Attribute Terminology	Add new term to new codelist	- - -	Suicidal Risk Monitoring	
2019-09-27	CDISC-4027	Update	C15843	CDISC Synonym	Study Purpose Response	Study Purpose Response	Add new CDISC Synonym	- - -	Prophylaxis