Overview
The close-out visit marks the formal conclusion of a clinical trial at an investigative site and requires careful attention to ensure all regulatory, data, and accountability requirements are properly finalized. A thorough close-out visit protects both the sponsor and site by ensuring audit readiness and compliance with record retention requirements.
This checklist should be completed during the close-out visit, with all outstanding items documented and assigned for resolution. The site should be left prepared for potential future audits or inspections by regulatory authorities.
Pre-Close-Out Preparation
- All subjects completed or discontinued from study
- All CRF pages entered and queries resolved
- All SAE follow-up complete and documented
- Final monitoring visit completed with no critical outstanding items
- Close-out visit scheduled with PI and key site staff
- Close-out visit agenda prepared and communicated to site
- All necessary close-out documents and forms prepared
- Final IP reconciliation data available
- Database lock status confirmed or anticipated timeline known
- Site payment status reviewed
Final Regulatory Document Review
- Regulatory binder complete and audit-ready
- All protocol amendments filed with IRB approvals
- All IB updates filed with acknowledgments
- Final enrollment documented on screening/enrollment log
- Subject identification log complete and finalized
- Signature and initials log complete with all study staff
- Delegation of authority log shows proper delegation throughout study
- All safety reports filed chronologically
- Correspondence file complete and organized
- IRB continuing review approvals filed for entire study duration
- IRB approval for study closure obtained (or process initiated)
- Final study report requirements discussed
Final Source Document and Data Review
- All source documents accounted for and filed
- Any outstanding source document discrepancies resolved
- Final SDV completed to required percentage
- All CRF data entered and verified
- All data queries resolved and closed
- Protocol deviation log complete and finalized
- All corrections made according to proper procedures
- No outstanding data clarification forms
- Confirmation that database reflects accurate subject data
Final Informed Consent Review
- All consent forms present and properly executed
- Consent version tracking accurate throughout study
- Re-consent documentation complete where required
- Subject consent withdrawal documentation complete (if applicable)
- All HIPAA authorizations present and complete
Investigational Product Final Accountability
- Final IP inventory completed
- IP accountability log reconciled and finalized
- All IP discrepancies resolved and documented
- Instructions for IP return or destruction provided
- IP return shipment arranged or destruction authorized
- Documentation of IP return or destruction obtained
- Temperature logs complete for entire storage period
- Any temperature excursions documented and resolved
- Randomization/IWRS records reconciled with IP records
Laboratory and Specimen Closeout
- All lab requisitions reconciled
- Outstanding lab results obtained
- Retained specimens disposition instructions provided
- Local lab normal ranges filed for study duration
- Central lab certification documentation complete
Safety Reporting Closeout
- All SAEs followed to resolution or stabilization
- Final SAE status documented for each event
- All regulatory authority notifications completed
- Safety database reconciliation completed
- Outstanding medical queries resolved
Site Staff Communication
- Principal Investigator briefed on close-out status
- Study coordinator debriefed on outstanding items
- Site staff thanked for participation
- Site performance feedback provided (if appropriate)
- Future study opportunities discussed (if appropriate)
Record Retention Requirements
- Record retention requirements communicated and documented
- Retention period start date established and documented
- Sponsor contact information for retention period provided
- Site notification requirements for record changes explained
- Site responsibility for maintaining records confirmed
- Storage location for study records confirmed
- Site agreement to notify sponsor before record destruction obtained
Financial Closeout
- All invoices submitted by site
- Payment status reviewed with site
- Outstanding payments identified and timeline provided
- Procedure for final payment processing explained
- Site agreement to final budget reconciliation obtained
Equipment and Materials Return
- Study supplies inventoried
- Unused study materials collected or destruction authorized
- Sponsor-provided equipment return arranged
- EDC access termination timeline communicated
- IWRS/RTSM access termination confirmed
Close-Out Documentation
- Close-out visit confirmation letter requirements discussed
- Site acknowledgment of study completion obtained
- Site signature on close-out confirmation obtained
- All outstanding action items documented with timelines
- Responsible parties assigned for each action item
- Follow-up communication plan established
Post-Close-Out Activities
- Close-out monitoring report completed within required timeframe
- Close-out confirmation letter sent to site
- IP destruction certificate obtained (when applicable)
- Final payment processed
- Site file archived
- Study team notified of site closure completion
Close-Out Summary
Total Subjects Enrolled at Site: _________________
Outstanding Items at Close-Out: Document any items requiring post-visit resolution
Record Retention Period: _________________
Site Contact for Retention Period: _________________
Monitor: _________________ Date: _________________
PI Acknowledgment: _________________ Date: _________________
