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Study Status Reporting: Final

SponsorsTo ensure proper closeout of a site’s participation in a study, each site submits a Final Study Status Report Form. Submit this form only after all your site’s subjects have completed all study-related activities, including any follow-up as required by the protocol.

Participation includes actions such as office visits, telephone follow-up, survival follow-up, and unanticipated problem follow-up.

If no subjects were consented on your study, the PI/QI or designee must complete and submit the SmartForm or send a letter/email verifying no subjects have been consented on this study.

Final Study Status Reports may be submitted via:

After Schulman receives and reviews the report or letter, and any follow-up issues are resolved, we will issue a closure letter. Our closure letter confirms that enrollment is closed and all study-related activity is complete. If your site should not have been closed, please contact us by e-mail.

For multisite studies, Schulman does not require sponsors/CROs to submit a protocol-level final report form. You may contact Ongoing Review to confirm that no additional sites will be participating in the protocol, that all approved sites have completed all study-related activities including collection of identifiable data, and that the protocol may be closed with the Board. When all sites have been closed for the study, Schulman will issue a protocol closure letter to the designated sponsor/CRO contacts. Our closure letter confirms that enrollment is closed and all study-related activity is complete.

To reopen a site with the Board, submit a written request to reopen, including rationale and a completed Study Status Report. To reopen a study with the Board, submit a written request to reopen and a completed Protocol Continuing Review Form.