(approx 4 - 6 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/GCP Ethics Training (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)
  • VM Patients’ Bill of Rights - WIRB Version
  • Consent Form Instructions and Checklist
  • BRI Model Consent and HIPPA Template
  • Translation Certificate
• 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.
• Complete and send Impact Statements (contact your Unit Manager for more information)

***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.

• 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 crp@benaroyaresearch.org.

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