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title	CDASH DS Metadata Specifications

Controlled Terminology Code List

Metadataspec

Order	Question Text	Prompt

CRF

Case Report Form Completion Instructions

CDASH

Type	Collection Variable

Name

SDTMIG Target Variable

SDTM Target Mapping

Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What was the category of the disposition?	Disposition Category	If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.	Text	DSCAT	DSCAT	(DSCAT)		DISPOSITION EVENT
2	What is the trial epoch for this disposition event?	Epoch	Select the study epoch for which disposition is being recorded.	Text	EPOCH	EPOCH	(EPOCH)	SCREENING; PRODUCT EXPOSURE; FOLLOW-UP;
3	What was the completion/discontinuation date?	Completion/Discontinuation Date	Record the date that the subject completed the study or study

period using this

period using this format. If the subject did not complete the study or study period, record the date that the subject discontinued.	Date	DSSTDAT	DSSTDTC
4	What was the subject's status?	Status	Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation.	Text	DSDECOD	DSDECOD		(

NCOMPLT)

TNCOMPLT

COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP

; NON-COMPLIANCE WITH STUDY PRODUCT; PHYSICIAN DECISION

;

PREGNANCY;

PROTOCOL DEVIATION; SCREEN FAILURE; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT;

WITHDRAWAL BY SUBJECT; OTHER.
5	What was the verbatim reason for the subject status?	Specify	If Adverse Experiences, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.	Text	DSTERM	DSTERM
6	Will the subject continue into the next epoch?	Continue	Record if the subject will be continuing to the next study period of this study.	Text			NOT SUBMITTED	(NY)	No; Yes
7	What is the next epoch the subject will continue to enter?	Next Epoch	Record the planned subsequent study epoch in which the subject intends to participate.	Text			NOT SUBMITTED	(EPOCH)	PRODUCT EXPOSURE; FOLLOW-UP

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