Regulatory Close-Out Procedures
What are the steps you need to take to close out your study?
When you complete your study, there are several procedures to follow to finalize the project. These include internal and external processes.
Internal/UTSW Regulatory Processes
- Human Research Protection Program Department (HRPP)/IRB: Studies approved by the UT Southwestern IRB must be inactivated upon completion of the study. A study is considered complete when all the following are true:
- Enrollment is closed
- Data is no longer being collected
- Analysis is complete or involves only de-identified data
- Any necessary approvals have been obtained (e.g., from a federal sponsor)
- Study activities at all sites are completed if UTSW or affiliate is the lead site for a multisite trial
- SPA: If your study involved funding, the Sponsored Programs Administration (SPA) website provides comprehensive tools and resources to help you close out your award.
- REDCap: Move your REDCap project to Analysis/Cleanup status if data collection is complete (i.e., when formal data collection has ended, except for cleaning and analyzing the data already collected) and to Completed once you are finished with a project, you are sure that no one needs to access it anymore, and you want to ensure that the project and its data remain intact.
FDA: The UTSW Sponsor Investigator support team can assist you with determining what steps need to be done and with preparing close-out documentation for FDA-regulated research, including the IND/IDE process.
Reporting Results on clinicaltrials.gov
- Registration and Reporting of Results on clinicaltrials.gov are required for studies that meet certain criteria. Use the ClinicalTrials.gov Decision Support Tree to determine whether reporting of results is required for your study.
- Need assistance in reporting results to clinicaltrials.gov? Contact CT.gov Support: CTgov@UTSouthwestern.edu or schedule a one-on-one meeting.
For more information, visit Sponsor Investigator Support.