Clinical Trial Process Outline

1. MD/ Research person submits items for Contract Packet to CRA (Clinical Research Administrator)  (can submit via scanned copies – but MUST have original copies of any signed piece contract at some point)

• Contract Packet Contains:
  • Conflict of Interest Form
  • Clinical Trial Summary
  • Facility Checklist
  • Host Facility agreement
  • Clinical Trial Agreement
  • Sponsor’s Budget
  • Medicare Coverage Analysis
  • Informed Consent
  • Protocol

2. MD/ Research Person deliver Contract Packet to Operations Manager of CMM (Covenant Medical Management) for review.  (ONLY IF your group part of CMM)

3. Operations Manager CMM approves Contract Packet and notifies CRA.

4. CRA reviews Conflict of Interest Form.

5. CRA will review appropriate pieces of information with particular facility (facilities).

6. CRA sends insurance section of packet for our Risk Management review.

7. CRA sets up meeting with CAO of facility / facilities for their review and approval after CRA has reviewed all information.

8. CAO signs contract.

9. CRA notifies IRB Administrator and Research Person of CAO approval.

10. CRA makes copies of signed contract and sends back to appropriate physician researcher to obtain sponsor signatures.

11. CRA invoices for $1000 F&A (Facilities & Administrative) Research Department Fee, if this is an industry sponsored clinical trial.

• CRA will invoice for F&A fee & IRB Administrator will invoice for IRB fee.
• The Fee for F&A fee must be paid by separate check and addressed to specific facility.  (Invoice will contain this specific information) :
• If more than one facility utilized then fee applies for each facility.
• F&A fee due same time as IRB fee due.
• F&A fee is a one time fee.