2. IRB Submission
Submit final version of all documents related to the study in eRA.
3. IRB Process
The submitted materials will be reviewed as Exempt or Expedited in the IRB Office, or referred to a convened board for review. Resulting determination will be Incomplete, Approved, Modifications Required, or Deferred.
4. Post Approval
Download approved documents from eRA and begin research. If changes to the research are needed, submit an amendment to the IRB. Report events when required.
5. Maintain Approval
IRB approval expires after one year. In order for the research to continue, and IRB approval to be maintained, submit a continuing review annually.
After all research-related procedures are complete and the data has been de-identified, close the study with the IRB by submitting a Final Report.