What the FDA's AI Guidance Means for COA Methodology in Clinical Trials

AI is transforming how clinical trial data is collected, monitored, and analyzed — but until now, no unified regulatory framework existed to govern its use in regulatory decision-making. The FDA's inaugural AI guidance, issued in early 2025, changes that. For sponsors relying on AI to support patient-reported outcome collection, data quality monitoring, or endpoint adjudication, the stakes are significant.

This white paper from Signant Health's scientific and regulatory experts examines how the new risk-based framework applies to COA methodologies, what "black box" AI means for your regulatory submissions, and how to build a credibility assessment strategy that keeps your program on the right side of compliance.