Contracts & Budgets (draft)

All clinical trials require a confidential disclosure agreement (CDA) and a clinical trial agreement (CTA) that includes a budget with payment terms.

The contract specialist works on the CDA first. Once the CDA is complete, the legal terms of the CTA are negotiated by the contract specialist and the budget and payment terms of the CTA is negotiated by the budget specialist in tandem.

The OCTR negotiates industry-sponsored or investigator-initiated industry-supported contracts, university-to-university agreements, co-operative group contracts and foundation-supported contracts, which include the following:

• Clinical Trial Agreements (CTA)
• Master Clinical Trial Agreements (MCTA)
• Confidentiality Disclosure Agreements (CDA)
• Contract Amendments
• Letters of Indemnification (LOI)

For any other contract types, please reach out to SPS.

Contract Negotiation Process

The contract negotiation process is dependent on the type of agreement:

Industry Sponsored Clinical Trial Agreements

• The sponsor will initially send a non-disclosure agreement (NDA) or a confidentiality disclosure agreement (CDA) to the researcher. Once received, the researcher should forward the CDA to the contract specialist in the OCTR. The CDA will then be reviewed, negotiated, approved, and executed. Thereafter, the researcher will review the data and the study components in order to determine whether to participate in the study.
• After reviewing the sponsor’s data and proposed study, the researcher and the sponsor will make a mutual decision whether or not to engage in the study. If the researcher decides to engage in the study, the sponsor will send a clinical trial agreement (CTA) to the researcher or the researcher’s study coordinator. The clinical trial agreement is then forwarded to the contract specialist in the OCTR for review and negotiation. Once the CTA is negotiated, the contract specialist will obtain signatures from an authorized representative of UConn Health, the researcher, and the sponsor.

University to University Agreements

• University to University agreements are subcontracts with a university that has a governing contract with a company sponsor. The negotiation procedure for University to University agreements is similar to the negotiation procedure for industry-sponsored clinical trial agreements.

Investigator-Initiated Clinical Trial Agreements

• An investigator-initiated clinical trial is one that is authored by the investigator and financially supported by industry, a foundation, or another university. The funding agency may send its own company contract to OCTR for negotiation, or OCTR may send the funding agency a clinical trial agreement generated by UConn Health. Thereafter, the negotiation procedure is generally tantamount to the process described above for industry-sponsored studies.

Cooperative Group Studies

• UConn Health has master agreements with cooperative groups which are designed to promote and support clinical trials. OCTR negotiates all agreements pertaining to the cooperative group studies or its corresponding master contract.

The budget development and negotiation process generally includes the following: 

• The sponsor or funding agency provides the proposed budget and/or budget template to the researcher/study team. The budget should be forwarded to OCTR for review and negotiation (octrclinicaltrial@uchc.edu). 

• OCTR performs a Medicare coverage analysis by reviewing the protocol, schedule of events, and creates an internal proposed budget to identify the costs associated with conducting the study at UConn Health. 

• OCTR works with the study team and applicable UConn Health department(s) to obtain appropriate internal costs for study-related services and resources. 

• OCTR develops and negotiates the study budget to ensure that clinical procedures, laboratory testing, pharmacy services, imaging, pathology, personnel effort, administrative activities, and other study-specific expenses are appropriately reflected in the budget. 

• OCTR negotiates the proposed budget with the sponsor or funding agency and works with the study team to address questions or requested revisions. 

• Once the budget has been negotiated and finalized, OCTR coordinates with the contract specialist, as necessary, to ensure that the final budget is consistent with the terms of the applicable agreement. 

• Budget amendments may be required when changes to the protocol, schedule of events, study procedures, personnel, internal costs, or other study-related requirements result in additional costs. OCTR reviews and negotiates applicable budget changes to ensure that the revised budget appropriately reflects the costs of conducting the study.