This standard defines a framework for classifying, representing, and standardizing operational activities, functional domains, and technology ecosystems across the clinical trial lifecycle, including planning, design, initiation, conduct, monitoring, analysis, and reporting. It establishes a common taxonomy and reference model for clinical trial functions, system interactions, and interoperable digital ecosystems. It further defines a structured framework for developing and harmonizing domain-specific standards by identifying boundaries, interfaces, and dependencies across domains, enabling consistent representation and integration of clinical trial digital ecosystems, including interventional trials and adjacent regulated evidence-generation activities such as real-world evidence and pragmatic or hybrid designs. The standard specifies requirements for organizing clinical trial activities and defining relationships between functional domains, supporting systems, and data flows, including cross-domain capabilities such as Quality by Design (QbD), Artificial Intelligence (AI), decentralized trials, cybersecurity, and data governance. The standard supports alignment with global regulatory frameworks and foundational standards, without defining clinical practice or regulatory policy.
- Standard Committee
- EMB/Stds Com - Standards Committee
- Status
- Active PAR
- PAR Approval
- 2026-06-04
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
- Standard Committee
- EMB/Stds Com - Standards Committee
- Working Group
-
CTOE WG - Clinical Trial Operational Ecosystems Working Group (CTOE WG)
- IEEE Program Manager
- Christian Orlando
Contact Christian Orlando - Working Group Chair
- Mathew Rose
Other Activities From This Working Group
Current projects that have been authorized by the IEEE SA Standards Board to develop a standard.
No Active Projects
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No Superseded Standards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No Inactive-Withdrawn Standards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