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 or draft budget.)
- 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 email within 48 hours of PEER acceptance of matter, identifying the Contract Analyst assigned to negotiate your agreement.
OCM's target timeframe to review, contact department, make changes as necessary or 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 the budget has been reviewed and approved by the Department of Finance Clinical Trials Billing Compliance Office. Therefore, it is critical for OCM to receive sponsor budget and StarBRITE eSMART Uber ID # as soon as possible.
Q: Why does The Clinical Trials Billing Compliance Office need to review all clinical studies at VUMC?
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):
- StarBRITE Charge Intention ID #
- The Final Budget to be incorporated into the agreement with sponsor.
Below are some of the provisions required in a Clinical Trial or Industry Sponsored agreement. OCM will review and negotiate these terms with the other party to insure that they meet VUMC Institutional Policies as handed down from the Office of Research and Office of Legal Affairs
- Legal Name (should be "Vanderbilt University 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)
- Intellectual Property
- Subject Injury (if human subjects are involved) -- Memo from Vice Chancellor Jacobson on Vanderbilt's Policy on Subject Injury Liability
- Sponsor Insurance
- Model Clinical Agreement Template
- Fact Sheet on Clinical Trial Publication Registration (For more information, please contact Research Support Services)