(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 GCP Training (all key personnel)
  
• Complete Ethics Training (all key personnel)
  
• 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 Disclosure Statements (more information)
• Final IRB approved protocol (e.g., UW, FHCRC, Group Health, etc)
• 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, 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
  Nursing Impact Statement	Laboratory/Pathology Impact Statement

***You MUST have feasibility approval before proceeding to Step 3***

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 (include pop-up to explain where to submit subcontract), if necessary.

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

• 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.
• IRB Application Coversheet etc. as applicable) via hardcopy to BRI IRB.

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

5. Submit study synopsis to appear on BRI website

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

Other Start-Up Forms and Guidelines

Study Start-Up Checklist
Study Start-Up Tracking Checklist
BRI Feasibility Review Process for Clinical Research
Scientific Merit Review
Consent Form Instructions and Checklist
HIPAA - Auth. to Use & Disclose Protected Health Information (PHI) Form
HIPAA - Waiver of Auth. for Use & Disclosure of Protected Health Information (PHI) Form
HIPAA - Waiver for Recruitment of Subjects by Non-VM/BRI Persons