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

Study Start-Up Checklist and Forms:

1. Create Protocol (using Intervention template)

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

2. Research Requirements

• Inform Unit Manager of impending study
• Submit Request for IRB and Funding numbers form, if applicable (includes Key Personnel List)
• Complete GCP Training (all key personnel)
  
• Complete Ethics Training (all key personnel)
  
• Financial Disclosure Statements (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 (including Patients’ Bill of Rights – VM Version)
  • Consent Form Model Template
  • Consent Form Instructions and Checklist
  • Model HIPPA Authorization Template
  • Translation Certificate
• Draft Internal Budget
• Data Collection Form(s)
• CTA / 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
  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 IRB documents to the IRB office at MS: D4-CRP (click here for BRI IRB meeting/deadline schedule)

• Full Review (please contact Unit Manager for more information)
• IRB Application Cover Sheet
• 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

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