11b. Closeout Form
Federal regulations require that primary investigators (PIs), or other principal parties, must file either a Continuing Review Application (CRA) or a Closeout Report prior to IRB approval expiration (date indicated on the approval letter). Upon approval of a Closeout Report, oversight by the SU IRB concludes.
A PI must submit a Closeout Report in the following circumstances:
Data has been permanently de-identified (with no possibility of future identification of subjects by code or otherwise). [This case typically applies to multi-site research, where a sponsor receives the de-identified data and authorizes SU IRB closure.]