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
2020-09-25	CDISC-4558	Add	C174271	Term	Protocol Entity Terminology	Protocol Entity Terminology	Add new term to existing codelist	- - -	Study Product	
2020-09-25	N/A	Add	C174447	Term	Protocol Entity Terminology	Protocol Entity Terminology	Add new term to existing codelist	- - -	Study Arm	C15538 is being replaced with C174447 in this codelist. 'Study Arm' was incorrectly assigned to C15538, which encompasses a more specific term 'Treatment Arm'.
2020-09-25	CDISC-4558	Add	C15538	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Treatment Arm	C15538, previously assigned to the concept 'Study Arm' is being re-assigned to the correct concept of 'Treatment Arm'; as not all arms in a study are treatment arms. This change is correcting a mis-coding.
2020-09-25	CDISC-4558	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	
2020-09-25	CDISC-4558	Add	C174226	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Control Arm	
2020-09-25	CDISC-4558	Add	C174266	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Experimental Arm	
2020-09-25	CDISC-4558	Add	C174267	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Active Comparator Arm	
2020-09-25	CDISC-4558	Add	C174268	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Placebo Comparator Arm	
2020-09-25	CDISC-4558	Add	C174269	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	Sham Comparator Arm	
2020-09-25	CDISC-4558	Add	C174270	Term	Study Arm Type Value Set Terminology	Study Arm Type Value Set Terminology	Add new term to new codelist	- - -	No Intervention Arm	
2020-09-25	CDISC-4558	Add	C174220	CDISC Codelist	Study Product Attribute Terminology	Study Product Attribute Terminology	Addition of new codelist	- - -	Study Product Attribute Terminology	
2020-09-25	CDISC-4558	Add	C174265	Term	Study Product Attribute Terminology	Study Product Attribute Terminology	Add new term to new codelist	- - -	Study Product Type	
2020-09-25	CDISC-4558	Add	C116527	Term	Study Product Type Value Set Terminology	Study Product Type Value Set Terminology	Add new term to new codelist	- - -	Sham Comparator	
2020-09-25	CDISC-4558	Add	C142587	Term	Study Product Type Value Set Terminology	Study Product Type Value Set Terminology	Add new term to new codelist	- - -	Investigational Product	
2020-09-25	CDISC-4558	Add	C142703	Term	Study Product Type Value Set Terminology	Study Product Type Value Set Terminology	Add new term to new codelist	- - -	Control Product	
2020-09-25	CDISC-4558	Add	C174221	CDISC Codelist	Study Product Type Value Set Terminology	Study Product Type Value Set Terminology	Addition of new codelist	- - -	Study Product Type Value Set Terminology	
2020-09-25	CDISC-4558	Add	C49648	Term	Study Product Type Value Set Terminology	Study Product Type Value Set Terminology	Add new term to new codelist	- - -	Placebo Comparator	
2020-09-25	CDISC-4558	Add	C68609	Term	Study Product Type Value Set Terminology	Study Product Type Value Set Terminology	Add new term to new codelist	- - -	Active Comparator	
2020-09-25	CDISC-4307	Add	C174366	Term	TTYPE	Trial Type Response	Add new term to existing codelist	- - -	REACTOGENICITY	
2020-09-25	N/A	Remove	C15538	Term	Protocol Entity Terminology	Protocol Entity Terminology	Remove term entirely from codelist	Study Arm	- - -	C15538 is being replaced with C174447 in this codelist. 'Study Arm' was incorrectly assigned to C15538, which encompasses a more specific term 'Treatment Arm'.
2020-09-25	CDISC-4558	Update	C142175	CDISC Definition	Clinical Study Attribute Terminology	Clinical Study Attribute Terminology	Update CDISC Definition	Describes the role the study plays in determining the interventions a subject receives.	The nature of the investigation for which study information is being collected. (After clinicaltrials.gov)	
2020-09-25	CDISC-4558	Update	C49660	CDISC Definition	Clinical Trial Attribute Terminology	Clinical Trial Attribute Terminology	Update CDISC Definition	The type of primary outcome or endpoint that the protocol is designed to evaluate. (clinicaltrials.gov)	The nature of the interventional study for which information is being collected.	
2020-09-25	CDISC-4558	Update	C170557	CDISC Definition	Endpoint Attribute Terminology	Endpoint Attribute Terminology	Update CDISC Definition	A characterization or classification of the identified endpoint(s) for the study.	A characterization or classification of the defined variable intended to reflect an outcome measure of interest that is statistically analyzed to address a particular research question.	
2020-09-25	CDISC-4558	Update	C165861	CDISC Definition	Outcome Measure Attribute Terminology	Outcome Measure Attribute Terminology	Update CDISC Definition	A characterization or classification of the identified outcome measure(s) for the study.	A characterization or classification of the specific key measurement(s) or observation(s) used to measure the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.	
2020-09-25	CDISC-4558	Update	C147140	CDISC Definition	Study Design Attribute Terminology	Study Design Attribute Terminology	Update CDISC Definition	The type of randomization method used to assign particpants to treatment groups or cohorts.	A characterization or classification of the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.	
2020-09-25	CDISC-4558	Update	C165864	CDISC Definition	Study Oversight Entity Attribute Terminology	Study Oversight Entity Attribute Terminology	Update CDISC Definition	The type of oversight entity for the study.	A characterization or classification of the group of individuals that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study participants, by providing critical scientific, ethical, and/or regulatory oversight functions.