A study may be closed 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, or data have been obtained (no further collection of data/information from or about living individuals will be obtained).
- No further contact with subjects is necessary (all interactions or interventions are complete).
- Analysis of subject identifiable data, records, specimens are complete (use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors, if appropriate).
In order for a PI to close an IRB protocol, submission of a Closure in Cayuse IRB is required. Once the closing report has been received by the IRB Office, a confirming e-mail will be sent to the PI and the Faculty Sponsor (if applicable) to document protocol closure.
Administrative Closures: in cases where a PI does not submit a CR or a Final Report within 30 days of the expiration of IRB approval, these studies will be administratively closed by the IRB Office and recorded as non-compliant.