Trial Closeout Operation


Clinical Trial Close-out is the act of ensuring that all clinical trial related activities are appropriately reconciled, recorded and reported at the end of a trial in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s). Usually the checklist for this visit includes

1. Review the project scope and ensure all activities are fully completed.
2. Examine the project documentation for completeness and accuracy including signatures and dates.
3. Finalize payments and reports.
4. Update inventory and ensure that any unused materials are returned or properly disposed of in accordance with appropriate guidelines.
5. Submit a final report, including documentation of all project deliverables, to all partiesinvolved in the project

6. When possible, conduct a closeout meeting with all team members to acknowledge the accomplishments of the project.