For Sponsors, CROs, and Single-Site Studies
The following documentation must be submitted for consideration during Board review of any federally-funded research:
- Standard Single Site Study Submission Documentation – Standard Multisite Study Submission Documentation
- A completed IRB Authorization Agreement listing your organization’s Federalwide Assurance number (FWA).
- A copy of the grant application if you are submitting as the “awardee institution”. Please submit supporting documentation if the grant has been previously reviewed by another IRB.
- A list of key personnel working on the project and documentation that they have completed Protection of Human Subjects Training ( OHRP’s video training series, CITI or equivalent).