Safety

Trials define the governed trial context. Safety planning lives in the Trial Summary sections Safety reporting, Oversight, and Stopping rules: adverse-event definitions, reporting expectations and collection configuration, committee responsibilities, and stopping rules inside that context. There is no standalone Safety planning surface.

Why it matters

• a trial needs agreed safety definitions, reporting expectations, and stopping rules
• safety decisions need to stay linked to the correct trial
• teams need to separate the main record from safety-specific handling

Participant-level event reporting and safety case processing remain in the responsible operational systems. Historical Safety records stay readable through the immutable history endpoints.

From each side

• Use Trials for the overall trial record.
• Use Trial Safety for the safety workflow and review now owned by Trial Summary.