Disposition -Study Dispostion

	Disposition Category DSCAT Hidden/pre-populated	DISPOSITION EVENT <DSCAT codelist>
Document the subject's status at study completion. If the subject discontinued prematurely, record the primary reason for discontinuation.	What was the subject's status? DSDECOD	COMPLETED ADVERSE EVENT DEATH DISEASE RELAPSE LACK OF EFFICACY LOST TO FOLLOW-UP NON-COMPLIANCE WITH STUDY DRUG PHYSICIAN DECISION PREGNANCY PROGRESSIVE DISEASE PROTOCOL DEVIATION RECOVERY SITE TERMINATED BY SPONSOR STUDY TERMINATED BY SPONSOR TECHNICAL PROBLEMS WITHDRAWAL BY PARENT/GUARDIAN WITHDRAWAL BY SUBJECT <NCOMPLT codelist>
If Adverse Event is selected from the Status list, provide the verbatim reason.	Specify DSTERM	_________________
Record the date that the subject completed the study using this format (DD-MON-YYYY). If the subject did not complete the study, record the date that the subject discontinued.	Study Completion/Discontinuation Date DSSTDAT DSSTDTC	_ _ / _ _ _ / _ _ _ _
Record the time (as complete as possible) that the subject completed the study. If the subject did not complete the study, record the time (as complete as possible) that the subject discontinued.	Study Completion/Discontinuation Time DSSTTIM DSSTDTC	_ _ : _ _ : _ _

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	Controlled Terminology Code List Name	CRF Implementation Notes	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
DSCAT	1	What was the category of the disposition?	Disposition Category	If collected on the CRF, the sponsor provides instructions to ensure the data is entered as intended.	Text	DSCAT	(DSCAT)			DISPOSITION EVENT	prompt		Yes
DSDECOD	2	What was the subject's status?	Status	Document the subject's status at study completion. If the subject discontinued prematurely, record the primary reason for discontinuation.	Text	DSDECOD	(NCOMPLT)	The Controlled Terminology (NCOMPLT) is focused on disposition events, and is used when DSCAT is "DISPOSITION EVENT".	COMPLETED; ADVERSE EVENT; DEATH; DISEASE RELAPSE; LACK OF EFFICACY; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY DRUG; PHYSICIAN DECISION; PREGNANCY; PROGRESSIVE DISEASE; PROTOCOL DEVIATION; RECOVERY; SITE TERMINATED BY SPONSOR; STUDY TERMINATED BY SPONSOR; TECHNICAL PROBLEMS; WITHDRAWAL BY PARENT/GUARDIAN; WITHDRAWAL BY SUBJECT			radio
DSTERM	3	If adverse event, specify	Specify	If Adverse Event is selected from the Status list, provide the verbatim reason.	Text	DSTERM		If DSTERM was collected as an adverse event, Specify", populate the SDTMIG variable DSTERM with the free text and populate DSDECOD with the standardized text from (NCOMPLT).			prompt
DSSTDAT	4	What was the study completion/discontinuation date?	Study Completion/Discontinuation Date	Record the date that the subject completed the study using this format (DD-MON-YYYY). If the subject did not complete the study, record the date that the subject discontinued.	Date	DSSTDTC
DSSTTIM	5	What was the study completion/discontinuation time?	Study Completion/Discontinuation Time	Record the time (as complete as possible) that the subject completed the study. If the subject did not complete the study, record the time (as complete as possible) that the subject discontinued.	Time	DSSTDTC

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Disposition -Study Dispostion