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, to the IRB 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 industry-sponsored, the sponsor or sponsor representative has agreed the study may be closed at this site.
Please complete the closure of your study via the eIRB system within 30 days of study closure using the activity “Edit Notice of Study Closure.” The form must be submitted by the study PI using the activity “Submit Notice of Study Closure.”
Before closing your study, 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 previously approved by the full board, that are permanently closed to enrollment, all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects are considered active and must receive annual continuing review. However, these studies may receive expedited review.
Example: An oncology study in which all of the research activities have concluded, with the exception of the collection of survival data on enrolled subjects, would satisfy the criteria for expedited review.
References and Additional Guidance
UT Southwestern record retention policy: "Records Retention Schedule" (internal link).
Food and Drug Administration (FDA) guidance: section 21 CFR 312.