This recommended practice defines requirements, controls, and best practices for the responsible, transparent, and ethical use of Artificial Intelligence (AI) in modern clinical research. The recommended practice focuses specifically on Clinical Development and allied activities. It specifies minimum criteria for data quality, performance monitoring, human oversight, risk management, and documentation to help ensure that artificial intelligence systems used in clinical trial design, conduct, analysis, and reporting operate safely, reliably, and in compliance with applicable regulatory expectations. The recommendation practice covers AI methods used across the spectrum of clinical research activities. It also incorporates Good Clinical Practice (GCP) aligned lifecycle controls, expectations for regulatory grade evidence, safeguards for bias and fairness, and interoperability with foundational data standards, while aligning with regulatory agency AI principles to help ensure consistent, trustworthy, and globally harmonized use of AI in clinical development.
- 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
- AICT WG - AI in Clinical Trials
- IEEE Program Manager
- Christian Orlando
Contact Christian Orlando - Working Group Chair
- Sandeep Bhat
Other Activities From This Working Group
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