(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 Ethics/GCP 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 see more information.
  
• Sponsor’s final Protocol
• Sponsor’s Informed Consent Form(s) (including VM Patients’ Bill of Rights - WIRB Version )
  
• Draft Informed Consent(s) if applicable
  • BRI Model Consent and HIPPA Template(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.
• Complete and send applicable 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.
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.

• IDE Medicare Billing Preauthorization Checklist
• Medicare IDE Part A Request
• Medicare IDE Part B Request

6. Enter study into CTMS

• Complete CTMS or Internal Study Budget Template and submit to Research Unit Manager

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***