Humanitarian Device Trials

(approx 4 - 6 weeks from submission to enrollment)

Below are the necessary startup checklists and forms for Humanitarian Device Trials at Benaroya Research Institute.

Study Start-Up Checklist and Forms:

1. Research Requirements.

2. Clinical Research Program (CRP) Feasibility - Submit all documents to CRP@BenaroyaResearch.org

***MUST have feasibility approval before proceeding to Step 3***

3. Submit Clinical Trial Contract/Agreement Review Request to CTA@BenaroyaResearch.org (if applicable).

4. Determine which external IRB will be used.  Review the Instructions on Choosing an external IRB.

5. Enter study into CTMS ONLY if a budget is required.

6. Submit study synopsis to appear on BRI website by contacting us at crp@benaroyaresearch.org.

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