Trial Monitoring

Keep oversight current

flowchart LR
    Signal[Operational signal] --> Oversight[Trial Summary Oversight]
    Oversight --> Review[Reviewable oversight]

There is no standalone Monitoring module. Teams maintain the current monitoring picture — critical-to-quality factors, risks, controls, quality signals, breach actions, and review obligations — in the Trial Summary Oversight section, with accountable scoped contacts and same-trial governed links. Legacy Monitoring URLs redirect to the trial detail surface, and historical Monitoring records stay readable through the immutable history endpoints.

Treat monitoring as a living record

The Oversight section exists so oversight information can evolve with full history instead of living in disconnected notes or one-time setup fields.

Use it while the trial is moving

Use this workflow when monitoring information needs to be updated, reviewed, compared, or restored over time as the operational situation changes.

Keep it tied to governance

Monitoring often overlaps with safety and broader governance review. Teams should keep those connections visible when a monitoring change has downstream impact.