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Clinical Trials Resource Group

Clinical Trials Resource Group

Activity #6: Approval by Health System Contracts (only applicable to Industry-Sponsored Studies)

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Activity #6: Approval by Health System Contracts (only applicable to Industry-Sponsored Studies)

Clinical Trials Contracts negotiates industry funded clinical trial agreements for the Health System.

 

Clinical trial agreements handled at HS Contracts office have all the following characteristics:

  • Involve prospective testing in Human Subjects and always require Institutional Review Board (IRB) review (this does not include cadaver or animal studies, nor does it include retrospective chart reviews)
  • Examine the efficacy, safety or benefits of a Food and Drug Administration (FDA) reviewed medical Intervention involving a drug, device, treatment or diagnostic (this would typically not include studies which involve the effects of beverages, foods or exercise on health, for example)
  • Fully funded, directly or indirectly, by a for-profit entity (agreements which are partially or fully funded by non-profit, state or federal entities cannot be reviewed by this office)

Industry-funded Clinical Trial Packet (Clinical Trials Contracts)

 Clinical Trial Packet

 

UC Davis School of Medicine Grant/Contract Transmittal Form

Mandatory

OVCR Data Sheet for Contract and Grant Proposals

Mandatory

State of California Financial Disclosure Form 700-U (Statement of Economic Interests). Required for both Principal Investigators (PI) and co-PIs.

Mandatory, requires ORIGINAL signature (ink)

Federal Financial Disclosure Form 800 (Statement of Economic Interests) for Government Sponsored Programs and Projects involving Human Subject Research. Required for both PI and co-PI.

Mandatory

Statement of Economic Interests Supplemental Form (required if positive disclosure on 700U or 800)

Mandatory, if applicable

Principal Investigator Statement of Exception to University of California Policy for Intellectual Property (Clinical Trials Contract Request Forms)

Mandatory

Request for Exception to California Policy on Eligibility to Submit Proposals (Form SRM 105A)

Mandatory, if applicable

Feasibility Assessment - at the discretion of Departments

At the Department's discretion

Coverage Analysis: Billing Grid

Mandatory for protocols that require billing through UCDHS Billing System (New and Amendments)

Internal Study Budget 

Mandatory in Unified Budget Template (UBT) format

IRB Packet (including protocol)

Mandatory

Sponsor Protocol

Mandatory

Sponsor Clinical Trials Agreement

Mandatory

Sponsor Budgets

Mandatory

Clinical Trial Packet

The department prepares the clinical trial packet and routes to the SOM Dean’s Office for approval. The complete list of forms is available online

Dean’s Office Review

The Dean’s Office School of Medicine Sponsored Programs reviews, approves the clinical trial packet, and routes to the Health System Contracts-Clinical Trials Contracts Office. The Clinical Trials Contracts Office negotiates and has final signature authority for the agreement.

Contract Office Receipt and Assignment

Once the contract packet is received by the contracts office it is assigned to an analyst for review, negotiation and final execution. The analyst will work with the department contact if there are missing elements or delays with negotiations. Conflict of interest documents are reviewed and submitted to Conflicted of Interest Committee for approval as appropriate. This review may be concurrent with contract negotiation, but must be approved prior to IRB approval and prior to Institutional Signature of the contract.

 Contract Office Initial Review

The analyst will review the contract for consistency with UC policy, state and federal law, using the budget, protocol and internal forms as necessary. The analyst may also seek consultation with Risk Management, UCDHS Legal, IRB, UCOP or other sources as necessary to complete the initial review.

Contract Office First Comments to Sponsor

The analyst will send a marked copy of the agreement to the sponsor with a copy to the PI and department. Where reasonable, the analyst will keep the PI and department copied on correspondence with the sponsor or provide reasonable updates on the agreement.

 Contract Negotiation

The analyst may need to consult with the department, PI, IRB, UCDHS Legal, Risk Management, Innovation Access, UCOP and other sources during the negotiation process in order to move the agreement forward and ensure compliance with UC policies and applicable laws.

End of Negotiation and PI Approval

Once there is agreement between the analyst and the sponsor, the analyst will send the agreement to the PI and department contact for final review and approval. If changes are requested, the analyst will negotiate any remaining issues with the sponsor. The contract will be held at this point until the PI has approved or the department contact certifies PI approval.

 Sponsor/Institutional Execution

Once approved by the PI, the contract will be sent for signature, typically starting with the PI signature of acknowledgement to the contract. After the PI signs the contract and all administrative requirements are met, the Director of Health System Contracts signs the agreement on behalf of UC. Typically the Sponsor signs last and the agreement is then fully executed. However, the contract will not be AWARDED until the IRB has approved the project.

 Contract Award

After the fully executed agreement is returned to Clinical Trials Contracts, and the IRB has approved the protocol, the HS Contracts- Clinical Trials notifies Extramural Accounting (EA). EA opens the extramural account and assigns the Office of the President (OP) fund number. This enables the Department to open the DaFIS and Bulk accounts to begin the study.

 Contract Maintenance

After the contract is executed, Clinical Trials Contracts will be responsible, upon request from the Department, to negotiate and execute amendments to the project period, budget, or other required changes to the contract as agreed between the sponsor and the PI and department. Such requests must originate from the department, rather than directly from the sponsor.

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