(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 Good Clinical Practices Training (all key personnel)
  
• Complete 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 Disclosure Statements (more information) for key personnel with known conflicts of interest
• Sponsor’s final Protocol
• Sponsor’s Informed Consent Form(s) (including VM Patients’ Bill of Rights - WIRB Version )
  
• Draft Informed Consent(s)
  
  • Consent Form Model Template
  • Consent Form Instructions and Checklist
  • Model HIPPA Authorization Template
  • Translation Certificate
• 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)
  

  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 3***

3. Submit Clinical Trial Contract/Agreement Review Request to CTA@BenaroyaResearch.org.

4. Submit Institutional Review Board (IRB) documents for review and approval. Industry studies will be submitted electronically to Western IRB (WIRB) via BRI IRB at IRB@benaroyaresearch.org:

Simultaneous approval can occur if preauthorization of WIRB submission is granted.

• Complete BRI IRB Office Checklist for WIRB Application which includes the BRI IRB Application Cover Sheet.
• Complete WIRB Application  or Quorum Review Application.
• Attach applicable documents electronically (may need to copy on flash drive), e.g., recruitment materials, questionnaires, final protocol.
• Financial Disclosure Statements for all key personnel

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 Unit Manager

7. Submit study synopsis to appear on BRI website

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