Trial Safety

Keep safety decisions explicit

flowchart LR
    Safety[Safety module] --> Reporting[Reporting expectations]
    Reporting --> Review[Review]

Trial Safety is where teams maintain adverse-event definitions, reporting expectations, stopping rules, and other safety-sensitive trial data.

Separate safety stewardship from general editing

The safety module exists 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.