Clinical Trial Project Closeout Checklist

Project Information
Project Title Protocol Number
Principal Investigator Study Site(s)
Sponsor Date of Closeout
Closeout Checklist
Task / Item Completed Notes
All data and source documents verified and archived
All regulatory documents updated, signed and archived
Study drug/device returned or destroyed as per protocol
Final monitoring visit conducted
Final report submitted to sponsor
Final report/notification submitted to IRB/EC
Site equipment/supplies returned (if applicable)
Subject compensation and reimbursement completed
Database locked and transferred to sponsor
Essential documentation complete (Delegation logs, CVs, training logs, etc.)
Investigator’s final acknowledgment
Comments / Additional Notes
Prepared by (Name & Title): Date:
Reviewed by (PI/Sponsor): Date: