Interim Monitoring Visits
- Conduct Interim Monitoring Visits and Prepare Reports within 10 Business Days
- Serious Adverse Events (SAEs) Review:
- Review of Patient Charts
- Verify Case Report Forms (CRFs) for Accuracy and Completeness
- Verify SAEs are Reported to Sponsor and IRB
- Informed Consent Review
- Check Protocol Adherence
- Assess Subject Compliance
- CRF Review and Source Document Review (paper CRFs or eCRFs)
- Queries and Error Corrections (paper CRFs or eCRFs)
- Resolve Data Clarifications with Investigators
- Collect Completed CRF’s (if applicable)
- Perform On-Site Investigational Product Review and Accountability
- Trial Master File (TMF) Review
- Review and Update Regulatory Files as needed
- Maintain Training of Site Personnel
