IRB submissions that WILL BE accepted during the revised Common Rule form change period of 12/21/2018-1/21/2019:
- Submission responses – All types (highly recommend submitting responses as soon as possible to limit issues within iMedRIS and the IRB application).
- External IRB requests for administrative review
- Amendments for KPR and DSMBs
- Progress reports expiring between 12/10/2018 and 1/31/2019
- Final Reports
- Unanticipated Problems
- Protocol Deviations
- Suspension or premature termination by the sponsor or investigator
- Federal agency (ex. FDA) or sponsor audit/inspection documentation or correspondence
IRB submissions that WILL NOT BE accepted during the form change period of 12/21/2018-1/21/2019:
- All new research (Exempt, Expedited and Greater than Minimal risk)
- Progress reports expiring after 1/31/2019
- Amendments which require a revision to the currently approved IRB application (e.g., changes in consent process, inclusion/exclusion criteria, enrollment totals, or other protocol changes)
Please contact the IRB Office at 248-551-0662 with any questions.