(approx. 4 - 10 weeks from submission to enrollment)

Study Start-Up Checklist and Forms:

1. Create Protocol - Non Interventional Protocol Template

• Research Mentor/Unit Director should review draft of protocol
• 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 / Exempt Status (Certificate of Exemption)
• Consent Form or Waiver of Consent
  • Consent Form Instructions and Checklist
  • BRI Model Consent and HIPAA Template
  • Waiver of Authorization for Use and/or Disclosure
    of Protected Health Information (“PHI”) for Research
  • Translation Certificate

• Database / Data Collection Form
  
• Feasibility Checklist
• Protocol
  
• Draft Internal Budget, if applicable
• Clinical Trials Agreement/Contract/Supplemental Funds or other types of support, if applicable
• Complete and send applicable Impact Statements (contact your Unit Manager with questions)
  

  Device Impact Statement						Radiology Impact Statement
  Pharmacy Impact Statement						CRC Impact Statemen CRC Med Order Sample CRC FAQ's
  Nursing Impact Statement						Laboratory/Pathology Impact Statement

***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.

5. Submit Institutional Review Board (IRB) documents to the IRB office at MS: D4-CRP (click here for BRI IRB meeting/deadline schedule)

•  Expedited Review Application. Please contact Unit Manager for more information.
• All applicable study documents, e.g., Full Protocol, Consent Form, HIPPA Authorization

For additional assistance, contact the IRB at IRB@BenaroyaResearch.org

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***