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.
- Submit Request for IRB and Funding Numbers form (please include all Key Personnel) to CRP@BenaroyaResearch.org
- Complete (all key personnel)
- Submit BRI / Investigator Compact (only for investigators new to research or new to VMMC).
2. Clinical Research Program (CRP) Feasibility - Submit all documents to CRP@BenaroyaResearch.org
- Human Subjects Research Study Evaluation Checklist form, aka the “feasibility checklist”
- Financial Relationship Disclosure Statement (more information) for key personnel with known conflicts of interest OR
- E Financial Disclosure Statement (Email Template) - More Information
- Sponsor’s final Protocol or Summary
- Draft Informed Consent(s) (if required by Sponsor or FDA)
- Draft Sponsor Clinical Trails Agreement / Budget or other types of support (if applicable)
- Draft Internal Budget (if applicable).
- Obtain applicable letter(s) from Sponsor - HDE# and letter.
***MUST have feasibility approval before proceeding to Step 3***
4. Determine which external IRB will be used. Review the Instructions on Choosing an external IRB.
- WIRB: Complete the BRI IRB WIRB Application Coversheet and Checklist and the WIRB Application.
- Quorum Review IRB: Complete the BRI IRB Quorum Review IRB Application Coversheet and Checklist and the Quorum Review Application.
- Attach applicable documents electronically (may need to copy on flash drive), e.g., recruitment materials, questionnaires, final protocol.
- Financial Relationship Disclosure Statement for all key personnel
5. Enter study into CTMS ONLY if a budget is required.
6. Submit study synopsis to appear on BRI website by contacting us at firstname.lastname@example.org.
***CRP “Letter to Commence” MUST be received before any study activity can occur***