This recommended practice describes a set of useful considerations that can be applied when assessing the impact of a decentralized clinical trial on patient safety. The recommended practice can be applied to clinical trials that decentralize all patient visits or a subset of patient visits.
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Trial Use Recommended Practice for Decentralized Clinical Trials Threat Modeling, Cybersecurity, and Data Privacy
This recommended practice describes a set of minimum requirements and useful considerations that can be applied to threat modeling when assessing the cybersecurity and data privacy of protocol design and technology implementation for decentralized clinical trials.