Investigator-Initiated Trial (IIT) – Non-Interventional (e.g., Database, Survey)

(approx. 4 - 10 weeks from submission to enrollment)

Study Start-Up Checklist and Forms:

1. Create Protocol - non_interventional _protocol_template.doc

  • Statistical consultant available upon request

2. Research Requirements

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

  • Database / Data Collection Form
  • Protocol
  • Draft Internal Budget, if applicable
  • Clinical Trials Agreement/Contract/Supplemental Funds or other types of support, if applicable

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

4. Submit for any Clinical Trial Agreement/Contract or Supplemental Fund Negotiations along with Review Request 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***