Safety

Trials define the governed trial context. Safety is the planning surface for adverse-event definitions, reporting expectations, responsibilities, and stopping rules inside that context.

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.

From each side

• Use Trials for the overall trial record.
• Use Trial Safety for safety-specific workflow and review.