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.
- Sponsor Committee
- EMB/Stds Com - Standards Committee
Learn More - Status
- Active PAR
- PAR Approval
- 2021-02-10
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
Learn More - Sponsor Committee
- EMB/Stds Com - Standards Committee
Learn More - Working Group
-
DCTPS - Decentralized Clinical Trials Patient Safety
Learn More - IEEE Program Manager
- Malia Zaman
Contact - Working Group Chair
- walter DE BROUWER
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.
No Active Standards
No Superseded Standards
No Inactive-Withdrawn Standards
No Inactive-Reserved Standards