Close-Out Clinical Research Site Visits & Audits
WEP expertly manages close-out site monitoring visits and audits at the end of a clinical trial to ensure all data is finalized, regulatory compliance is met, and site responsibilities are properly closed. Our process follows Good Clinical Practice (GCP) and regulatory guidelines (FDA, EMA, MHRA, etc.).
Pre-Close-Out Preparation
Before the actual close-out visit, WEP ensures:
- All patient visits are completed and no outstanding follow-ups remain
- All case report forms (CRFs) and source data are verified for accuracy
- Data queries are resolved in the Electronic Data Capture (EDC) system
- Regulatory documents (e.g., informed consent forms, IRB/EC approvals) are up to date
- Investigational Product (IP) reconciliation is completed to ensure all drugs/devices are accounted for
Key Documents Reviewed Before Close-Out
- Trial Master File (TMF)
- Investigator Site File (ISF)
- Source Documents & CRFs
- Delegation of Responsibilities Log
- Adverse Event (AE/SAE) Reports
Conducting the Close-Out Visit
WEP’s CRAs or Site Monitors visit the sites and carry out the following tasks:
Final Data Review & Verification
- Ensure all data discrepancies are resolved.
- Confirm audit trails in the EDC system.
- Ensure proper documentation of protocol deviations or violations.
Investigational Product (IP) Reconciliation & Return
- Verify drug accountability logs.
- Ensure all unused study drugs/devices are returned or destroyed per protocol.
- Check that temperature logs and storage conditions comply with regulations.
Regulatory & Ethics Compliance
- Confirm the site retains all required documents for archival (15+ years per ICH-GCP).
- Ensure IRB/EC final reports are submitted.
- Verify compliance with Good Documentation Practices (GDP).
Final Safety & AE Reporting
- Ensure all Adverse Events (AEs), Serious Adverse Events (SAEs), and safety reports are submitted.
- Ensure follow-up visits for patient safety are completed.
Site Staff & Investigator Responsibilities
- Confirm the Investigator’s Statement is signed to confirm:
- No further data collection is required.
- The site’s obligations under ICH-GCP are met.
- Train site staff on data archiving and record retention.
- Discuss any audit/inspection preparations.