(approx. 4-8 weeks from submission to enrollment)

Study Start-Up Checklist and Forms

1. Research Requirements

• Submit Request for IRB and Funding Numbers form (includes Key Personnel list)
• Complete Ethics/GCP Training (All key personnel.  Exceptions may be granted.)
• Non-BRI / VMMC research staff working on campus with data or patients must complete outside access documentation.*
• Submit BRI / Investigator Compact (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 “feasibility checklist) – includes Financial Relationship Disclosure Statement (more information) OR E Financial Disclosure Statement (Email Template) - More Information
• Final Institutional Review Board (IRB) approved protocol (e.g., UW, FHCRC, Group Health, etc)
• Draft Informed Consent(s) (including Patients’ Bill of Rights – VM Version)
  • Consent Form Instructions and Checklist
  • BRI Model Consent and HIPPA Template
  • Translation Certificate
• Draft Internal Budget, if applicable
• Subcontract or Agreement, if applicable
• Complete and send any 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 CRC FAQ's
  Nursing Impact Statement						Laboratory/Pathology Impact Statement

3. Submit Complete Clinical Trial Contract / Agreement Review Request to grants and contracts at GRANTS@BenaroyaResearch.org, VMMC Foundation, or Contracts Negotiator CTA@BenaroyaResearch.org, if necessary.

4. Submit IRB documents

• Cooperative Review Application
• Applicable documents, including; most recent approval from IRB of Record, all applicable documents (informed consent, recruitment materials, etc...), stamped "approved" by the IRB of Record.

For additional assistance, contact the IRB at IRB@BenaroyaResearch.org

Submit all relevant documents in electronic form to CRP@benaroyaresearch.org.  Do not send signed application until requested.

The study will undergo review and changes will be requested or approval will be granted followed by a request for signed documents.  The study will then be submitted to the BRI IRB.

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

*If key personnel are being added that will have direct interaction with VMMC subjects or be coming onto the VMMC campus, see links to guidance and forms below:

• Access for Outside Research Staff
• Annual Renewal for Outside Research Staff Access
• Unaffiliated Investigator Agreement
• Non-VM Investigator Patient Approach Procedures