Study Closure Guidance
When a research project has been completed, a report must be submitted to the IRB to provide a final report of the project. The Notice of Study Closure should be completed and submitted via the eIRB system when all of the following apply:
- All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing),
- All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained),
- No further contact with subject is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary),
- Analysis of subject identifiable data is no longer necessary (i.e., subjects’ records will no longer be required or all data/specimens have been de-identified. This includes review of source documents by study sponsors, and
- If the study is industry-sponsored, the sponsor or sponsor's representative has agreed the study may be closed at this site.
Within 30 days of the study's ending, a notice of study closure must be created using the activity “Edit Notice of Study Closure,” and submitted by the study PI using the activity “Submit Notice of Study Closure” in the main study workspace, eIRB.
Before closing the study via eIRB, the investigator and research personnel should be sure that all paperwork for the study is in order and complete. This includes reporting of all Adverse Events prior to study closure.
Note: Studies that remains active only for long-term follow-up of subjects are considered active and must receive annual continuing review.
References and Additional Guidance
- Food and Drug Administration (FDA) guidance: section 21 CFR 312.
- UT Southwestern record retention policy: Records Retention Schedule (Available on MyUTSW, the campus intranet).