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

Study Start-Up Checklist and Forms:

1. Create Protocol (using Intervention Protocol Template)

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

2. Research Requirements

• Inform Research Unit Manager of impending study
• Submit Request for IRB and Funding numbers form, if applicable (includes Key Personnel List)
• Complete Ethics/GCP Training (all key personnel)
• Financial Relationship Disclosure Statement (for all Key Personnel) - for more information  OR
  E Financial Disclosure Statement (Email Template) - More Information
• Submit BRI/Investigator Compact (for investigators new to research or new to VMMC)
• IND Exemption Checklist, or Form FDA 1571. May use checklist, e.g., when test article under study is FDA approved for that particular disease, does not change the route of administration or is supported by mulitple publications for clinical use. If none of these are applicable, see FDA Instructions for more information and completing Form FDA 1571.
• Form FDA 1572. Investigator Statement for IND use.
  

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)
  • Consent Form Instructions and Checklist
  • BRI Model Consent and HIPPA Template
  • Translation Certificate

• Draft Internal Budget
• Financial Relationship Disclosure Statements (for any Key Personnel with Conflict of Interest)
• Data Collection Form(s)
• Clinical Trials Agreement/Contract/Supplemental Funds, if applicable
• Complete and send applicable 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 Institutional Review Board (IRB) documents to the IRB office at MS: D4-CRP (click here for BRI IRB meeting/deadline schedule)

• BRI IRB Full Review Application (please contact Unit Manager for more information)
• 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 by contacting us at crp@benaroyaresearch.org. 

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