(approx 4 - 6 weeks from submission to enrollment)

Study Start-Up Checklist and Forms:

1. Research Requirements.

• Submit Request for IRB and Funding Numbers form (please include all Key Personnel) to CRP@BenaroyaResearch.org
• Complete GCP Training (all key personnel)
• Complete Ethics Training (all key personnel)
• Submit BRI / Investigator Compact (only 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 the “feasibility checklist”
• Financial Disclosure Statements (more information) for key personnel with known conflicts of interest
• Sponsor’s final Protocol or Summary
• Draft Informed Consent(s) (if required by Sponsor or FDA)
  • Consent Form Model Template
  • VM Patients’ Bill of Rights - WIRB Version
  • Consent Form Instructions and Checklist
  • Model HIPPA Authorization Template
  • Translation Certificate
• Draft Sponsor CTA / Budget (if applicable)
• Draft internal budget (if applicable).
• Obtain applicable letter(s) from Sponsor - HDE# and letter.
• Complete and send Impact Statements (contact your Unit Manager for more information)

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

3. Submit Clinical Trial Contract/Agreement Review Request to CTA@BenaroyaResearch.org (if applicable).

4. Submit IRB documents for review and approval. Industry studies will be submitted electronically to Western IRB (WIRB) via BRI IRB at IRB@benaroyaresearch.org:

Simultaneous approval can occur if preauthorization of WIRB submission is granted.

• Complete BRI IRB Office Checklist for WIRB Application.
• Complete WIRB Application and
• Attach applicable documents electronically (may need to copy on flash drive), e.g., recruitment materials, questionnaires, final protocol.
• Financial Disclosure Statements for all key personnel

5. Enter study into CTMS ONLY if a budget is required.

6. Submit study synopsis to appear on BRI website

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