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
- Isaac Rodriguez-Chavez
Other Activities From This Working Group
Current projects that have been authorized by the IEEE SA Standards Board to develop a standard.
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.
Standards approved by the IEEE SA Standards Board that are within the 10-year lifecycle.
No Active Standards
These standards have been replaced with a revised version of the standard, or by a compilation of the original active standard and all its existing amendments, corrigenda, and errata.
No Superseded Standards
These standards have been removed from active status through a ballot where the standard is made inactive as a consensus decision of a balloting group.
No Inactive-Withdrawn Standards
These standards are removed from active status through an administrative process for standards that have not undergone a revision process within 10 years.
No Inactive-Reserved Standards