Study Close-Out Visit

What is a Study Close-Out Visit:

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!

Few of the checklist items but not limited to:

• Delegation Log will be updated with end dates

• IRB Closure (CRC to inform IRB that Study is getting closed)

• Archiving (How long the study records will be maintained in Site)

• IP Reconciliation

• Clinicaltrials.gov closure (updating the study status to indicate the conclusion of the study and to post study results.

• Post-Award Closure (to ensure that all financial and cost standards have been met with institutional guidelines, sponsor guidelines, and federal regulations).

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