(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 GCP 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 CTA / Budget
• Obtain applicable letter(s) from Sponsor - IND, IND Exemption, IDE, 510K, etc.
• Complete and send Impact Statements (contact your Unit Manager for more information)
  

  Device Impact Statement	Radiology Impact Statement
  Pharmacy Impact Statement	CRC Impact Statement
  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 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.
• Complete WIRB Application and
• 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***