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. Itincludes 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 fordisposition 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
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Example
This 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.