Clinical Trial Agreement (CTA) Provision

A Clinical Trial Agreement (CTA) Provision is healthcare-related agreement provision in a CTA agreement.

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References

2023

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  • Several resources like the Clinical Trial Agreements (CTA) Toolkit by the American Health Law Association (AHLA) exist to help attorneys and investigators understand and navigate these agreements. The toolkit outlines key provisions in a CTA from both the sponsor's and the clinical trial site's perspectives, along with related laws, case law, and operational considerations.

     Terms like indemnification, gross negligence, and third-party beneficiary law are key in the understanding of these agreements. For instance, indemnification, a provision where a party agrees to protect another from potential harms, needs careful articulation to avoid extensive liability.

    Furthermore, via an investigator's survey, a majority agreed to the need for their active involvement in the CTA process, which engages their understanding of complex areas like establishing the contract's date, dealing with backdating, and possible risks associated with the words in the agreement.

    Another important aspect features in the role of the Institutional Ethics Committee (IEC) in approving CTAs and insurance policies related to clinical trials. The IEC checks agreements for mandatory clauses defining responsibilities that align with guidelines like the New Drugs and Clinical Trial Rules (NDCTR). This study also noted that a thorough understanding of the scope of CTAs and related insurance policies is vital for investigators, who also need to be aware that the law of the land supersedes any agreement.

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