Regulatory Open Forum

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  • 1.  CTAs and device agreements

    Posted 05-May-2022 12:03
    Hello everyone, wondering if there is a best practice for documenting the lease of a medical device for use in a clinical study.  Would this be negotiated as part of the Clinical Trial Agreement (CTA) or through a separate lease agreement? I appreciate your feedback!

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    Sandra Veenstra
    Director - Quality Assurance and Regulatory Affairs
    Moncton NB
    Canada
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