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The Disposition Events (DS) domain is an event domain that contains information encompassing and representing data related to subject disposition. It provides an accounting for all subjects who entered the study. It includes disposition events and protocol milestones (e.g., informed consent obtained, randomized). Applicants may choose which disposition events and milestones/other events to submit for a study. See ICH E3, Section 10.1, for information about disposition events.

In the DS domain, DSCAT is used to distinguish between disposition events, protocol milestones, and other events. The controlled terminology for DSCAT consists of "DISPOSITION EVENT", "PROTOCOL MILESTONE", and "OTHER EVENT". The data collection scenario is similar for disposition events that are considered protocol milestones or other events, whereas the data collection scenario for subject disposition events is different.  

Disposition events 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-study product exposure follow-up. The codelist (NCOMPLT) is used for DSDECOD. The codelist (NCOMPLT) is only used when DSCAT = "DISPOSTION EVENT". 

Example

This is an example CRF used to collect informed consent. 

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Example

his is an example CRF used to collected dispostion at the end of each epoch of a trial. Additionally, the CRF is used to collect information on the next epoch entered for adminstrative reason and this data is not submitted.

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This is an example SDTM dataset used to represent the data collected on the above example CRFs and information on randomization. 
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 product exposure, during the screening epoch.
Rows 3-5:Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "PRODUCT EXPOSURE", "FOLLOW-UP").
Row 7:Shows disposition of a subject who was a screen failure. The Disposition CRF showed that the subject discontinued for a " PROTOCOL DEVIATION ". The specify reason the subject was a screen failure was then collected using DSTERM. Because the subject did not complete the screening epoch, DSDECOD is not “COMPLETED” but another appropriate controlled term, "PROTOCOL DEVIATION ". 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 protocol exposure epoch. For completed epochs, both DSTERM and DSDECOD are "COMPLETED". For epochs that were not completed, the verbatim reason for non-completion of the product exposure epoch is in DSTERM, while the value from controlled terminology is in DSDECOD.
Rows 14-16:Show disposition of a subject who completed product exposure epoch, 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 product exposure epoch due to an adverse experience, but who went on to complete the follow-up epoch of the trial.

ds.xpt

ds.xpt

RowSTUDYIDDOMAINUSUBJIDDSSEQDSTERMDSDECODDSCATDSSCATEPOCHDSDTCDSSTDTC
1ABC123DS1231011INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-212003-09-21
2ABC123DS1231012RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-09-302003-09-30
3ABC123DS1231013COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-09-302003-09-29
4ABC123DS1231014COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-312003-10-31
5ABC123DS1231015COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2003-11-152003-11-15
6ABC123DS1231021INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-11-212003-11-21
7ABC123DS1231022SUBJECT DENIED MRI PROCEDUREPROTOCOL VIOLATIONDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-11-222003-11-20
8ABC123DS1231031INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-152003-09-15
9ABC123DS1231032RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-09-302003-09-30
10ABC123DS1231033COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-09-302003-09-22
11ABC123DS1231034SUBJECT MOVEDLOST TO FOLLOW-UPDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-312003-10-31
12ABC123DS1231041INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-152003-09-15
13ABC123DS1231043RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-09-302003-09-30
14ABC123DS1231042COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-09-302003-09-22
15ABC123DS1231044COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-152003-10-15
16ABC123DS1231045AUTOMOBILE ACCIDENTDEATHDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2003-10-312003-10-29
17ABC123DS1231051INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE
SCREENING2003-09-282003-09-28
18ABC123DS1231052RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE
SCREENING2003-10-022003-10-02
19ABC123DS1231053COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2003-10-022003-10-02
20ABC123DS1231054ANEMIAADVERSE EXPERIENCEDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2003-10-172003-10-17
21ABC123DS1231055COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2003-11-022003-11-02
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