Required Forms

WIRB® SUBMISSIONS: All submissions to WIRB® should be dropped off at the Office of Human Subject Protection (OHSP) in Room 1-7009 at the Medical Center. In addition to all study documents, the University of Rochester's Application for Industry-Sponsored Research Review and the WIRB® Initial Review Submission Form are required for review. Please note that the WIRB® online submission process may not be used for the initial submission.

Forms

• Required University of Rochester Application for Industry-Sponsored Research Review
  
• Compensation for Injury
• Materials needed for WIRB® Submission
  1. The signed printed RSRB on-line application
  2. Completed WIRB Application [including billing and sponsor/CRO contact information]
  3. Sponsor Protocol
  4. Subject Consent Form(s)
  5. Investigator's Brochure [for all drug studies, if current version is not on file with WIRB]
  6. IDE Documentation [for device studies only
  7. Signed FDA form 1572
  8. Study recruitment materials [ads, brochures, etc.]
  9. Investigators' current Medical License(s)
  10. Investigators' current CV's
  11. Departmental Letterhead
• WIRB® Submission Forms required for review.

Federalwide Assurance