flowchart LR A[Pre-Visit Preparation] --> B[On-Site / Remote Monitoring] B --> C[Issue Identification] C --> D[Follow-Up Letter] D --> E[Issue Resolution] E --> F[Documentation Complete]
25 Monitoring Workflow
25.1 End-to-End Monitoring Workflow
25.2 Pre-Visit Preparation
- Review protocol and amendments
- Review prior visit reports
- Identify outstanding issues
- Review EDC listings and queries
25.3 On-Site / Remote Monitoring
- Informed consent review
- SDV per monitoring plan
- Safety review (AEs / SAEs)
- IP accountability
- Facility and staff assessment
25.4 Post-Visit Activities
- Draft Monitoring Visit Report (MVR)
- Issue Follow-Up Letter
- Track action items to resolution