Cooperative Trials – Study Start-Up

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

Study Start-Up Checklist and Forms

1. Research Requirements

2. Clinical Research Program (CRP) Feasibility - Submit all documents to CRP@BenaroyaResearch.org

 

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: