This recommended practice defines a framework for applying Quality by Design (QbD) principles to the design, representation, and governance of Digital Clinical Trial Systems and Networks (DCTSN). It specifies requirements for standardized system network models, including structure, terminology, and risk-informed design elements, to support the integration and interoperability of clinical trial technologies across the trial lifecycle. The recommended practice addresses identification and management of critical-to-quality factors, system interactions, and traceability within digital workflows. It aligns with International Council for Harmonisation (ICH) E8(R1) and E6(R3) to help ensure support for participant protection and data reliability. It further establishes lifecycle controls, interoperability expectations, and conformance criteria for digital systems and networks, including alignment with foundational data and exchange standards, to help ensure that digital trial infrastructures are designed, implemented, and governed in a consistent, reliable, and regulatory-grade manner.
- 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
-
CTQbD WG - Clinical Technology Quality by Design Working Group
- IEEE Program Manager
- Christian Orlando
Contact Christian Orlando - Working Group Chair
- Mathew Rose
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