28 Monitoring Templates
28.1 Monitoring Visit Report (MVR)
Study:
Site:
Visit Type:
Visit Date(s):
CRA:
28.1.1 Summary
Overall site status and risk assessment.
28.1.2 Findings
| Area | Observation | Action Required |
|---|---|---|
| Informed Consent | ||
| SDV | ||
| Safety | ||
| IP Accountability |
28.1.3 Action Items
28.2 Follow-Up Letter Template
Date:
Study / Site:
28.2.1 Summary of Findings
Brief overview of key observations.
28.2.2 Required Actions
| Issue | Required Action | Due Date |
|---|