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: _________________