Contract Negotiation

In the case of industry sponsored clinical studies, contract negotiations happen in two steps or situations:

• First to put a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) in place, and then;
• If selected to participate in the study, to put a clinical trial agreement (CTA) in place.  

During negotiations, the university and the other party — the sponsor or a clinical research organization (CRO) managing the study on behalf of the sponsor or other entity — establish the legal parameters of their working relationship for the study. The basic required contract documents — consent, protocol, IRB approval, CDA, CTA —  are the same for every industry sponsored clinical study. However, the language in each of those documents is specific to the study and every contract negotiation is unique based on the type of study, site obligations, sponsor requirements and other details.

When is a DUA Required?

A Data Use Agreement (DUA) is mandatory whenever information or data is shared with any outside entity that is not affiliated with the University at Buffalo.

Exception: A DUA is not required for industry-sponsored multi-site clinical trials, as data sharing is already managed under the Clinical Trial Agreement (CTA).

What Types of Data Require a DUA?

A DUA is required for all types of data, including data sets that have been completely de-identified.

The provided form is designed to collect all the necessary information required to submit and complete a DUA request through the CLICK Agreements system.

• Legally binding with an explicit expectation of specific performance
• Highly structured; often includes detailed deliverables, timelines and clear penalties for non-compliance
• Typically used by industry or Federal agencies when procuring services or products

• Broad term that refers to any mutual understanding between parties
• Includes Contracts, but also encompasses foundational documents like Memorandums of Understanding (MOUs), Confidential Disclosure Agreements (CDAs), and Data Use Agreements (DUAs)
• Not all agreements are enforceable contracts- depends on intent and specific terms

• Financial assistance rather than a procurement mechanism
• Fewer strings attached and offers high flexibility in execution
• Awarded to support research in the public interest, usually by Federal or Non-profit sponsors
• The sponsor expects no direct benefit or product; the primary emphasis is on advancing knowledge

The negotiation process is critical to ensure that the university and the investigator are protected from liability, that all costs associated with the study will be paid, and to set clear performance expectations for both parties.

The CRO has a team of regulatory, budget and contract people available to assist in the process.

As an investigator, your assistance is critical. Your expertise is needed to answer specific questions regarding the CDA, CTA and to help with other study related documents during the negotiation process. There also may be times when CRO staff feel it is necessary and helpful to have you, the investigator, participate directly in the negotiation with the sponsor.

While the CRO reviews and revises contract documents as quickly and efficiently as possible, successful completion of a contract negotiation requires timely participation and cooperation of the sponsor/representative and the investigator/staff. Therefore, the total time to contract negotiation varies.