The DS domain, Disposition, 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). Sponsors may choose which disposition events and milestones/other events to submit for a study.
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.
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
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