- Published
- Updated
- Sources checked
A usable monitoring plan tells reviewers what matters, which evidence to examine and when to change the approach. A calendar of visits alone cannot explain how participant protection and reliable results are overseen.
Map critical processes
Map protocol-specific critical processes to a monitoring method: central checks, remote review or site visits. Define responsibility for consent process oversight, eligibility, safety reporting and endpoint collection. Explain which risks require direct discussion with the investigator.
Follow a missed assessment
For a time-sensitive endpoint assessment, specify the relevant source, review window, failure signal and escalation path. Link the monitoring finding to its resolution evidence. Distinguish an activity completed from a concern resolved, particularly when several teams share the action.
Monitoring plan checks
- State triggers for additional review or a change in visit frequency.
- Describe access arrangements and privacy controls before remote review.
- Define report review, action ownership and closure evidence.
Test the plan against a scenario
Accept the plan after a reviewer can apply it to one plausible missed-assessment scenario without inventing decision rules. Revisit the plan after meaningful protocol or risk changes and preserve the reason for the revised oversight approach. Ask a newly assigned monitor to apply the plan; identify critical steps that still depend on unwritten personal experience before approving wider use.
Frequently asked questions
- Must every site have the same visit schedule?
- Use a justified approach reflecting study and site risks, with appropriate oversight.
- Does fewer SDV checks mean less oversight?
- Not necessarily; assess the combined monitoring activities and the risks they address.