Clinical Trials/Industry Sponsored Agreements

Submission Procedures for Agreements with Human Subjects (other than Federal Grants & Subcontracts)

INITIAL SUBMISSION TO GCM

Submit a complete package to GCM. (Includes transmittal form, hard copy of contract, statement of work or protocol, other relevant documents/disclosures, and initial budget.)

KEY NOTES:

  • Final budgets are not required up front. (Contract negotiation between GCM and sponsor typically occurs simultaneously with the budget negotiation taking place between the department and the sponsor.)
  • You will receive an e-mail within 48 hours identifying the Contract Analyst assigned to negotiate your agreement.

GCM's target timeframe to review, make changes as necessary and send a redline draft to the sponsor is 5-10 business days from receipt of the complete package submittal from the department. Please keep in mind this is our goal, but due to workload and other circumstances it is not always possible.

HOSPITAL FINANCE REVIEW THROUGH GCM

CRITICAL: GCM will not sign your contract until it has been reviewed and approved by the Clinical Trials Billing Compliance Office. Therefore, it is critical for all the documents required for the finance review to be received by GCM as soon as possible.

  • Q: Why does The Clinical Trials Billing Compliance Office need to review all clinical studies at Vanderbilt? A: The Clinical Trials Billing Compliance Office in the Department of Finance must review the budget and certain parts of the contract for compliance with Medical Center and VUH billing policies and consistency with Medicare rules and private insurance provider agreements.
  • IMPORTANT: Effective February 12, 2007, all Hospital Finance Review materials must be submitted to GCM for initial review. GCM will submit directly to the Clinical Trials Billing Compliance Office for final approval, and GCM will work directly with you to resolve any issues related to the Hospital Finance Review.

WHAT TO SEND TO GCM: You will need to submit the following three items at or as soon as possible following the initial contract submission (NOTE: These documents are not required for GCM to open a new contract file, but will be required before the contract can be signed):

  • Two completed forms from the Clinical Trial Patient Cost Template spreadsheet; visit the Research Finance Website for more information about preparing your budget grid and review documents. (VUnet ID required).
    1. Patient Cost Worksheet
    2. Clinical Trials Registration Form
  • Also, the Final Budget to be incorporated into the agreement with sponsor.

Please note the documents required for initial contract submission to GCM have not changed.

Required Terms

These are some of the terms required in a Clinical Trial or Industry Sponsored agreement. GCM will review and negotiate terms with the other party that meet VU Institutional Policies as handed down from the Office of Research and Office of General Counsel.

  • Legal Name (should be “Vanderbilt University by and through its Medical Center”, not your department or division)
  • Official Address (should be 1161 21st Avenue South, Nashville, TN 37232, not your department or division street address and not the GCM address)
  • Notices (GCM required, departmental contact optional but recommended)
  • Conflict of terms (if agreement conflicts with attachments, exhibits or protocol, the contract terms must prevail)
  • Publications (VUMC/PI must have publication rights)
  • Confidentiality
  • Intellectual Property
  • Indemnification
  • Subject Injury (if human subjects are involved) -- Memo from Vice Chancellor Jacobson on Vanderbilt's Policy on Subject Injury Liability
  • Sponsor Insurance
  • Electronic systems security statement

Clinical Trial Knowledgebase for Administrators and Investigators

The following references are tasks which GCM does not perform as part of the contract review/negotiation process, but that departments may have questions about. We will add to this list from time to time as requests for information are received. The list will provide you with links to documents or contact persons appropriate for the topic.