Office of Contracts Management

Clinical Trials/Industry Sponsored Agreements

• Initial Submission to OCM
• Hospital Finance Review through OCM
• Required Contract Terms
• Additional resources

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

INITIAL SUBMISSION TO OCM

Submit a complete package to OCM via PEER. (include 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 OCM 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.

OCM'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.

HOSPITAL FINANCE REVIEW THROUGH OCM

CRITICAL: OCM will not sign your contract until it has been reviewed and approved by the Clinical Trials Billing Compliance Office. Therefore, it is critical for OCM to receive sponsor budget and FACTr ID# 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: All Hospital Finance Review materials must be submitted to OCM for initial review. OCM will submit directly to the Clinical Trials Billing Compliance Office for final approval, and OCM will work directly with you to resolve any issues related to the Hospital Finance Review.

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

• FACTr Study ID # **
• The Final Budget to be incorporated into the agreement with sponsor.

** Beginning March 1st, 2010: You are required to complete training on the new Financial Accountability and Compliance Tracking for Research (FACTr) sysem. This new web-based system has been created by the Department of Finance to replace completion of a patient cost template spreadsheet and will also be used to request an exemption for your clinical research studies. Afer completing the information required by FACTr, your study will be given a FACTr ID number. You must provide the FACTr # to OCM (a field is provided for the FACTr # in PEER electronic contract submissions). OCM can view the information directly in FACTr using the FACTr # as long as the project is marked submitted (not in draft form). rovide the FACTr ID number to OCM (a field is provided in PEER for electronic submissions). OCM can view the required information using the FACTr ID number as long as the project is marked submitted in FACTr (not in draft form). Visit the Clinical Trials Billing Compliance website for more information about use of the FACTr system (VUnet ID required).

Required Terms

These are some of the terms required in a Clinical Trial or Industry Sponsored agreement. OCM 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 OCM address)
• Notices (OCM 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

See Also

• Model Clinical Agreement Template
• Fact Sheet on Clinical Trial Publication Registration (For more information, please contact Research Support Services)