(approx. 8 - 16 weeks from submission to enrollment)

Study Start-Up Checklist and Forms:

1. Create Protocol (using Intervention Protocol 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 (for all Key Personnel) - for more information
• Submit BRI/Investigator Compact (for investigators new to research or new to VMMC)
• IND checklist to determine whether an IND application needs to be submitted to the FDA for studies involving FDA-approved drugs. FDA instructions for form 1571. FDA form 1571.

3. Clinical Research Program (CRP) Feasibility - Submit all documents to CRP@BenaroyaResearch.org

• 3-5 names for scientific review (CRP will conduct concurrent statistical review)
• Feasibility Checklist
• Final Protocol
• Draft Informed Consent(s) (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
• Financial Disclosure Statements (for any Key Personnel with Conflict of Interest)
• Data Collection Form(s)
• CTA / Supplemental Funds, if applicable
• Complete and send Impact Statements (contact your Unit Manager with questions)

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

4. Submit any Sponsor Clinical Trial Contract / Agreement along with Review Request for negotiations at 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)

• Full Review Application (please contact Unit Manager for more information)
• IRB Application Cover Sheet
• All applicable study documents, e.g., Final Protocol,Consent Form, HIPPA Authorization, Investigator Brochure

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***