Investigator-Initiated Trial (IIT) - Biologic or Gene Therapy

(approx. 6 - 8 months from submission to enrollment)

Study Start-Up Checklist and Forms

1. Create Protocol (using Intervention template)

  • Statistical consultant is available, if needed

2. Research Requirements

3. Clinical Research Program (CRP) Feasibility - Submit all documents to

***MUST have feasibility approval before proceeding to Step 4***

4. Submit Clinical Trial Contract / Agreement Review Request to for negotiations, if applicable.

5. All new study applications must be submitted using the eProtocol. Please visit the IRB page for additional guidance.

6. Submit study synopsis to appear on BRI website by contacting us at

***CRP “Letter to Commence” MUST be received before any study activity can occur***