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). Sponsors 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
This is an example CRF used to collect informed consent.
Order
Question Text
Prompt
Case Report Form Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instructions
Controlled Terminology CodeList Name
Permissible Values
Pre-Populated Value
1
What was the category of the disposition?
Disposition Category
If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.
Text
DSCAT
DSCAT
(DSCAT)
DISPOSITION EVENT
2
What is the trial epoch for this disposition event?
Epoch
Select the study epoch for which disposition is being recorded.
Text
EPOCH
EPOCH
(EPOCH)
SCREENING; PRODUCT EXPOSURE; FOLLOW-UP;
3
What was the completion/discontinuation date?
Completion/Discontinuation Date
Record the date that the subject completed the study or study period using this format. If the subject did not complete the study or study period, record the date that the subject discontinued.
Date
DSSTDAT
DSSTDTC
4
What was the subject's status?
Status
Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation.
Text
DSDECOD
DSDECOD
(TNCOMPLT
COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP; PROTOCOL DEVIATION; SCREEN FAILURE; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT; WITHDRAWAL BY SUBJECT; OTHER.
5
What was the verbatim reason for the subject status?
Specify
If Adverse Experiences, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.
Text
DSTERM
DSTERM
6
Will the subject continue into the next epoch?
Continue
Record if the subject will be continuing to the next study period of this study.
Text
NOT SUBMITTED
(NY)
No; Yes
7
What is the next epoch the subject will continue to enter?
Next Epoch
Record the planned subsequent study epoch in which the subject intends to participate.
Text
NOT SUBMITTED
(EPOCH)
PRODUCT EXPOSURE; FOLLOW-UP.
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.
