Clinical Trial Risk-Based Monitoring Plan Checklist
Document and review the monitoring plan for a clinical trial, including trial details, key risks, monitoring approach, and review status.
Trial Overview
Protocol Number or Study ID
*
Trial Title
*
Sponsor or Organization Name
*
Monitoring Plan Version/Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Risk Assessment and Monitoring Design
Primary trial risks to monitor
*
Informed consent issues
Protocol deviations
Safety reporting delays
Source data discrepancies
Missing or incomplete data
Investigational product accountability
Laboratory data anomalies
Other
Critical data/processes requiring centralized or on-site review
*
Monitoring approach chosen
*
Centralized
On-site
Hybrid
Other
Monitoring visit frequency / trigger plan
*
Responsible monitoring lead or role
*
Planned issue escalation pathway
*
Review and Completion
Overall Plan Status
*
Please Select
Draft
In Review
Approved
Key Gaps or Action Items
Reviewer Name and Role
*
Submit
Should be Empty: