Disposition

The DS domain provides an accounting for all subjects who entered the study. It includes disposition events and protocol milestones (e.g., informed consent obtained, randomized). Sponsors may choose which disposition events and milestones/other events to submit for a study.

This includes disposition events that describe a subject's completion status or reason for discontinuation of the entire study or a phase or segment of the study, including screening and post-treatment follow-up. The codelist used for DSDECOD is specific to this situation. (NCOMPLT) is used when DSCAT = "DISPOSTION EVENT".

Example CRF: Protocol milestones (e.g., informed consent)

	Disposition Category DSCAT DSCAT="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED" Hidden/pre-populated	PROTOCOL MILESTONE <DSCAT codelist>
Record the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).	What was the informed consent date? DSSTDAT DSSTDTC	_ _ / _ _ _ / _ _ _ _
Record the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.	What was the informed consent time? DSSTTIM DSSTDTC	_ _ : _ _ : _ _

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Value	SDTMIG Target Mapping	Controlled Terminology Code List Name	CRF Implementation Notes	Pre-Populated Value	Query Display	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="PROTOCOL MILESTONE" where DSDECOD and DSTERM="INFORMED CONSENT OBTAINED"	(DSCAT)	Refer to the SDTMIG for guidelines for assigning DSCAT, DSTERM, and DSDECOD for events considered protocol milestones.	PROTOCOL MILESTONE	prompt	Yes
DSSTDAT	2	What was the informed consent date?	Informed Consent Date	Record the date of informed consent as defined in the protocol and/or CRF completion instructions using this format (DD-MON-YYYY).	Date	DSSTDTC					qtext
DSSTTIM	3	What was the informed consent time?	Informed Consent Time	Record the time (as complete as possible) of informed consent as defined in the protocol and/or CRF completion instructions.	Time	DSSTDTC					qtext

Example CRF :Study Participation Disposition Event

	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

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.

ds.xpt

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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Disposition