Industry Sponsored Trials
(approx. 8 - 12 weeks from submission to enrollment)
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
- Financial Relationship Disclosure Statement see more information.
- Sponsor’s final Protocol
- Sponsor’s Informed Consent Form(s)
- Draft Informed Consent(s) if applicable
- (if no sponsor template)
- Consent Form Instructions and Checklist
- Draft Sponsor Clinical Trial Agreement (CTA) / Budget
- Draft Internal Budget
- Obtain applicable letter(s) from Sponsor - IND, IND Exemption, IDE, 510K, etc.
***MUST have feasibility approval before proceeding to Step 3***
3. Submit Clinical Trial Contract / Agreement Review Request to CTA@BenaroyaResearch.org.
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, WIRB Application and the WIRB Coverletter (request to copy documents to study coordinator
- Quorum Review IRB: Complete the BRI IRB Quorum Review IRB Application Coversheet and Checklist and the Quorum Review Application.
Complete Financial Disclosure Statements from Sponsor for all key personnel.
Submit Institutional Review Board (IRB) documents for review and approval. Industry studies will be submitted electronically to external IRBs via BRI IRB (flash drive available). Contact Rainier J. Reyes at ext. 11346 or rreyes@BenaroyaResearch.org for more information.
5. For device studies with IDE ONLY – obtain preauthorization for Part A / B following IRB approval.
6. Enter study into CTMS
7. 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***