Monitoring

Trials provide the governed trial record. Monitoring oversight lives in the Trial Summary Oversight section: critical-to-quality factors, risks, controls, quality signals, breach actions, and review obligations with accountable scoped contacts. There is no standalone Monitoring workflow surface.

Why it matters

• active trial execution needs ongoing monitoring
• monitoring decisions need to stay tied to the right trial
• reviewers need operational context around the monitored record

Historical Monitoring records stay readable through the immutable history endpoints.

From each side

• Use Trials for the overall trial record.
• Use Trial Monitoring for the monitoring workflow and review now owned by Trial Summary Oversight.