(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      CRC Med Order Sample
  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