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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). 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.
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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 DISPOSITION EVENT".
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This is an example CRF used to collect informed consent.
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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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