Site Close-Out
- Conduct Site Close-Out Visit and Prepare Site Close-Out Visit Report
- 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 a Final Investigational Product Inventory
- Prepare and Ship Investigational Product/ Study Supplies to Sponsor
- Review Trial Master File for Completeness
- Discuss Record Retention Requirements with Site
- Verify that the Site has Submitted Final Reports to IRB and Sponsor
