(approx. 6 - 8 months from submission to enrollment)

Study Start-Up Checklist and Forms:

1. Create Protocol (using Intervention template)

• Research Mentor/Unit Director should review draft of protocol
• Statistical consultant is available, if needed

2. Research Requirements

• Inform Research Unit Manager of impending study
• Submit Request for IRB and Funding numbers form, if applicable (includes Key Personnel List)
• Complete Ethics/GCP Training (all key personnel)
• Financial Relationship Disclosure Statement (more information) 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

• 3-5 names for scientific review
• NIH RAC Approval Letter
• Institutional Biosafety Committee (IBC) Approval Letter
• IND, IDE, HDE or Exemption Letter
• Feasibility Checklist
• Final Protocol
• Draft Informed Consent Forms.
  • Consent Form Instructions and Checklist
  • BRI Model Consent and HIPPA Template
  • Translation Certificate
• Draft Internal Budget
• Data Collection Form(s)
• Clinical Trials Agreement / Budget, if applicable
• Complete and send applicable Impact Statements (contact your Unit Manager for more information)
  

  Device Impact Statement						Radiology Impact Statement
  Pharmacy Impact Statement						CRC Impact Statement 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 Clinical Trial Contract / Agreement Review Request to CTA@BenaroyaResearch.org for negotiations, 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)

• BRI IRB Full Review Application  (please contact Unit Manager for more information)
• All applicable documents, e.g., questionnaires, recruitment materials, final protocol, etc.

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***