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Description

Disposition is an Events domain used for information encompassing and representing data related to subject disposition. It provides an accounting for all subjects who entered the study. The DS domain includes both disposition events and protocol milestones (e.g., informed consent obtained, randomized). Applicants may choose which disposition events and milestones/other events to collect for a study in alignment with regulatory requirements.

 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". This section describes 2 different data collection scenarios for the disposition domain. 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. 

Scenario 1: Protocol Milestone or Other Event

This scenario includes disposition events that are considered protocol-specified, point-in-time events and other events. Common protocol milestones include “INFORMED CONSENT OBTAINED” and “RANDOMIZED”;  "OTHER EVENT" includes other important events occurring during a study, but which were not driven by protocol requirements nor captured in another Events or Interventions class dataset. The codelist used for DSDECOD is specific to the scenario. (PROTMLST) is used when DSCAT = "PROTOCOL MILESTONE" and (OTHEVENT) is used when DSCAT = "OTHER EVENT".   

Scenario 2: Study Participation Disposition Event

This scenario 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 the scenario. (NCOMPLT) is used when DSCAT = "DISPOSTION EVENT".

Specification

Assumptions