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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 provides an accounting for all subjects who entered the study. It includes disposition events and protocol milestones (e.g., informed consent obtained, randomized). Sponsors Applicants may choose which disposition events and milestones/other events to submit for a study. . See ICH E3, Section 10.1 (available at https://www.ema.europa.eu/en/documents/), 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.
This includes disposition 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 study product exposure follow-up. The codelist (NCOMPLT) is used for DSDECOD is specific to this situation. The codelist (NCOMPLT) is only used when DSCAT = "DISPOSTION DISPOSITION EVENT".
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This is an example CRF used to collected disposition at the end of each epoch of a study. Additionally, the CRF is used to collect information on the next epoch entered for administrative reasons; this data is not submitted.
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