​Study Status Reporting: Final

Schulman IRB - Information for InvestigatorsTo 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.

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 a study at your site should not have been closed, please contact us by e-mail.

To reopen a study at your site, submit a written request to reopen, including rationale, sponsor/CRO approval and a completed Study Status Report Form.