Medical
Monitoring Visit Checklist for Clinical Trial
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Monitoring Visit Checklist for Clinical Trial

1
Prepare for the monitoring visit
2
Review Clinical Trial Protocol
3
Evaluate trial sites for potential issues
4
Check trial staff for necessary training and qualifications
5
Inspect patient recruitment and consent process
6
Review patient eligibility and enrollment
7
Review patient medical records and trial data for consistency and accuracy
8
Verify all serious adverse events (SAEs) are properly documented and reported
9
Inspect investigational product storage and management
10
Ensure all protocol deviations are documented and justified
11
Review trial documentation and ensure it is complete and up-to-date
12
Approval: Investigator
13
Discuss findings with investigator and trial staff
14
Document the monitoring visit findings
15
Prepare monitoring visit report
16
Forward monitoring visit report to project manager
17
Approval: Project Manager
18
Discuss corrective action plan if necessary
19
Follow-up on corrective action plan implementation
20
Reschedule next monitoring visit