Active PAR

P2968.2

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.

Sponsor Committee
EMB/Stds Com - Standards Committee
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Status
Active PAR
PAR Approval
2021-02-10

Working Group Details

Society
IEEE Engineering in Medicine and Biology Society
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Sponsor Committee
EMB/Stds Com - Standards Committee
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Working Group
DCTPS - Decentralized Clinical Trials Patient Safety
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IEEE Program Manager
Tom Thompson
Contact
Working Group Chair
walter DE BROUWER

P2968.1

Trial Use Recommended Practice for Decentralized Clinical Trials Patient Safety

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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No Active Standards
No Superseded Standards
No Inactive-Withdrawn Standards
No Inactive-Reserved Standards
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