(approx. 4 - 10 weeks from submission to enrollment)

Study Start-Up Checklist and Forms:

1. Create Protocol - Non Interventional Protocol Template

• Mentor/Unit Director should review draft of protocol
• Statistical consultant available upon request

2. Research Requirements

• Inform Unit Manager of impending study.
• Submit Request for IRB and Funding Numbers form, if applicable (include all Key Personnel)
• Complete GCP Training (all key personnel)
  
• Complete Ethics Training (all key personnel)
• Financial Disclosure Statements (more information), if applicable
• 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

• Expedited Review Checklist / Exempt
• Consent Form or Waiver of Consent (including Patients’ Bill of Rights – VM Version)
  • Consent Form Model Template
  • Consent Form Instructions and Checklist
  • Model HIPPA Authorization Template
  • Waiver of Authorization for Use and/or Disclosure
    of Protected Health Information (“PHI”) for Research
  • Translation Certificate

• Database / Data Collection Form
  
• Feasibility Checklist
• Protocol
  
• Draft Internal Budget, if applicable
• CTA / Supplemental Funds, if applicable
• Complete and send Impact Statements (contact your Unit Manager with questions)
  

  Device Impact Statement	Radiology Impact Statement
  Pharmacy Impact Statement	CRC Impact Statemen      CRC Med Order Sample
  Nursing Impact Statement	Laboratory/Pathology Impact Statement

***MUST have feasibility approval before proceeding to Step 4***

4. Submit for any CTA or Supplemental Fund Negotiations along with Review Request for Negotiationa CTA@benaroyaresearch.org if applicable.

5. Submit IRB documents to the IRB office at MS: D4-CRP (click here for BRI IRB meeting/deadline schedule)

• IRB Application Cover Sheet
• Expedited Review Application or Chart Review Application. Please contact Unit Manager for more information.
• All applicable study documents, e.g., Full Protocol, Consent Form, HIPPA Authorization

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***