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
- Inform Research Unit Manager of impending study.
- Submit Request for IRB and Funding Numbers form, if applicable (include all Key Personnel)
- Complete Ethics/GCP Training (all key personnel)
- Financial Relationship Disclosure Statement (more information), if applicable OR
- E Financial Disclosure Statement (Email Template) - More Information
- Submit BRI / Investigator Compact (for investigators new to research or new to VMMC)
3. Clinical Research Program (CRP) Feasibility - Submit all documents to CRP@BenaroyaResearch.org
- Expedited Review Application (Visit the IRB page for guidance)
- Consent Form or Waiver of Consent
- Database / Data Collection Form
- 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 CTA@benaroyaresearch.org if applicable.
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***