Trial Safety

Keep safety decisions explicit

flowchart LR
    TrialSummary[Trial Summary] --> Reporting[Reporting expectations]
    Reporting --> Review[Review]

There is no standalone Safety module. Teams maintain adverse-event definitions, reporting expectations, collection configuration, committee oversight, and stopping rules in the Trial Summary sections Safety reporting, Oversight, and Stopping rules, with full version history. Legacy Safety URLs redirect to the trial detail surface, and historical Safety records stay readable through the immutable history endpoints.

Separate safety stewardship from general editing

Safety sections exist because safety work needs a clearer review boundary than a generic edit path usually provides.

Use it when the risk profile changes

Use this workflow when safety definitions, reporting expectations, or stopping logic need to evolve as part of ongoing trial oversight.

Prefer reviewable changes

Safety-sensitive changes should be handled deliberately, with history and context preserved, because downstream interpretation matters as much as the latest value on the page.