Negotiating AI-Related Clauses in Contracts

About this session

AI provisions are appearing in clinical trial agreements, CRO master services agreements, vendor contracts, and data use agreements — often as hastily drafted boilerplate that neither party fully understands. This session provides practical negotiation guidance from both sponsor-side and site-side perspectives. We'll work through the clause categories that matter most: permitted and prohibited uses of AI in performing services, restrictions on inputting confidential or personal data into AI systems, training-data prohibitions, disclosure and transparency obligations, allocation of responsibility for AI-generated errors, intellectual property in AI-assisted work product, and audit rights. We'll review sample language, discuss common sticking points, and identify where a blanket prohibition creates more problems than it solves.

Takeaways

Recognize the core AI clause categories now appearing in research agreements

Evaluate sample language from both sponsor and site negotiating positions

Anticipate downstream operational consequences of restrictive AI provisions

Speakers

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  Jim Wagner

  SVP, AI and Product Innovation · WCG Clinical

  Speaker

• JM

  James Mantia

  Grants and Contracts Manager · Icahn School of Medicine at Mount Sinai

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• EJ

  Eli Judge

  Manager, Clinical Research Contracts and Compliance · WCG

  Speaker