Protocol Lifecycle1. Development

Review IRB Investigator Manual, complete CITI training, and design materials using IRB templates.

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.

6. Closeout

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.