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The Controlled Terminology is focused on disposition events, and is used when DSCAT is "DISPOSITION EVENT". If DSTERM was collected as an adverse event, Specify", populate the SDTMIG variable with the free text and populate DSDECOD with the standardized text from (NCOMPLT). 4

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	SDTMIG SDTM Target Mapping	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
EPOCH	2	What is the trial epoch for this disposition event?	Epoch	Select the trial epoch for which disposition is being recorded.	Text	EPOCH		(EPOCH)	SCREENING; TREATMENT; FOLLOW-UP;		prompt	radio
DSSTDAT	3	What was the completion/discontinuation date?	Completion/Discontinuation Date	Record the date that the subject completed the study or trial period using this format (DD-MON-YYYY). If the subject did not complete the study or trial period, record the date that the subject discontinued.	Date	DSSTDTC
DSSTTIM	4	What was the completion/discontinuation time?	Completion/Discontinuation Time	Record the time (as complete as possible) that the subject completed the study or trial period as defined in the protocol. If the subject did not complete the study or trial period, record the time (as complete as possible).	Time	DSSTDTC
DSDECOD	5	DSDECOD	2	What was the subject's status?	Status	Document the subject's status at study completionfor the study or trial period. If the subject discontinued prematurely, record the primary reason for discontinuation.	Text	DSDECOD(NCOMPLT)		(NCOMPLT)		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; OTHER			radio
DSTERM	36	If adverse eventother, specify	Specify	If Adverse Event or Other is selected from the Status list, provide the verbatim reason.	Text	DSTERM	DSTERM						promptDSSTDAT
DSCONT	7	Will the subject continue?	Continue	Record if the subject will be continuing to the next trial period of this study.	Text	SUPPDS.QVAL	SUPPDS.QVAL when SUPPDS.QNAM= "DSCONT" and SUPPDS.QLABEL="Subject Continue".	(NY)	No; Yes			radio
DSNEXT	8	What is the next epoch the subject will continue to enter?	Next epoch	Record the planned subsequent trial epoch in which the subject intends to participate.	Text	N/A		(EPOCH)	TREATMENT; FOLLOW-UP;	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

Dataset wrap

Name	ds

Rowcaps

Rows 1, 2, 6, 8, 9, 12, 13, 17, 18:	Show records for protocol milestones. DSTERM and DSDECOD are populated with the same value, the name of the milestone. Note that for randomization events, EPOCH = "SCREENING", because randomization occurred before the start of treatment, during the screening epoch.
Rows 3-5:	Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "TREATMENT", "FOLLOW-UP").
Row 7:	Shows disposition of a subject who was a screen failure. The verbatim reason the subject was a screen failure is represented in DSTERM. Because the subject did not complete the screening epoch, DSDECOD is not “COMPLETED” but another appropriate controlled term, "PROTOCOL VIOLATION". The date of discontinuation is in DSSTDTC. The protocol deviation event itself would be represented in the DV dataset.
Rows 10-11:	Show disposition of a subject who completed the screening stage but did not complete the treatment stage. For completed epochs, both DSTERM and DSDECOD are "COMPLETED". For epochs that were not completed, the verbatim reason for non-completion of the treatment epoch is in DSTERM, while the value from controlled terminology is in DSDECOD.
Rows 14-16:	Show disposition of a subject who completed treatment, but did not complete follow-up. Note that for final disposition event, the date of collection of the event information, DSDTC, was different from the date of the disposition event (the subject's death), DSSTDTC.
Rows 19-21:	Show disposition of a subject who discontinued the treatment epoch due to an adverse event, but who went on to complete the follow-up phase of the trial.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	EPOCH	DSDTC	DSSTDTC
1	ABC123	DS	123101	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-21	2003-09-21
2	ABC123	DS	123101	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
3	ABC123	DS	123101	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-29
4	ABC123	DS	123101	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-31	2003-10-31
5	ABC123	DS	123101	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-11-15	2003-11-15
6	ABC123	DS	123102	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-11-21	2003-11-21
7	ABC123	DS	123102	2	SUBJECT DENIED MRI PROCEDURE	PROTOCOL VIOLATION	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-11-22	2003-11-20
8	ABC123	DS	123103	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-15	2003-09-15
9	ABC123	DS	123103	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
10	ABC123	DS	123103	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-22
11	ABC123	DS	123103	4	SUBJECT MOVED	LOST TO FOLLOW-UP	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-31	2003-10-31
12	ABC123	DS	123104	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-15	2003-09-15
13	ABC123	DS	123104	3	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
14	ABC123	DS	123104	2	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-22
15	ABC123	DS	123104	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-15	2003-10-15
16	ABC123	DS	123104	5	AUTOMOBILE ACCIDENT	DEATH	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-10-31	2003-10-29
17	ABC123	DS	123105	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-28	2003-09-28
18	ABC123	DS	123105	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-10-02	2003-10-02
19	ABC123	DS	123105	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-10-02	2003-10-02
20	ABC123	DS	123105	4	ANEMIA	ADVERSE EVENT	DISPOSITION EVENT	STUDY PARTICIPATION	TREATMENT	2003-10-17	2003-10-17
21	ABC123	DS	123105	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-11-02	2003-11-02

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