Study Close-Out Visit

DEFINITION

• The Study Close-out Visit is a visit and process arranged by the sponsor of the research study to ensure that all necessary aspects of the study closure have been addressed, to include organization and completion of documentation and reporting.

Policies/Guidelines

• The study close-out visit occurs once participants are no longer receiving investigational treatment, all the data have been collected (there are no more outstanding adverse events & all outstanding queries/data clarification forms have been resolved appropriately), the database is locked and ready for statistical analysis, and the study conduct has ended.
  • This is the study monitor’s final visit to shut down the study at the site.
• The study monitor will ensure that everything is neat and tidy at the study site and that the documentation is well organized and will remain intact and be accessible in the future as needed for regulatory reasons.
  • If it isn’t documented, it didn’t happen!

Templates/Forms

• Study Close-out Visit Checklist 
  • Site Checklist (Word document created by the National Center for Complementary and Integrative Health (NCCIH))

• Provides an overview of what will be reviewed by monitors during a site visit.