Industry Sponsored Trials

(approx. 8 - 12 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

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

3. Submit Clinical Trial Contract / Agreement Review Request to CTA@BenaroyaResearch.org.
4. Determine which external IRB will be used.  Review the Instructions on choosing an external IRB.

Complete Financial Disclosure Statements from Sponsor for all key personnel.

Submit Institutional Review Board (IRB) documents for review and approval. Industry studies will be submitted electronically to external IRBs via BRI IRB (flash drive available).  Contact Rainier J. Reyes at ext. 11346 or rreyes@BenaroyaResearch.org for more information.

5. For device studies with IDE ONLY – obtain preauthorization for Part A / B following IRB approval.

6. Enter study into CTMS

7. Submit study synopsis to appear on BRI website by contacting us at CRP@BenaroyaResearch.org.

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