Anchoring AI Proof Certificates to Clinical Data Standards: A USDM-Based Implementation Framework for Regulatory Interoperability in Clinical Trials

This working paper proposes a field-level implementation framework for anchoring AI proof certificates natively within the CDISC Unified Study Definitions Model (USDM) without requiring new standards or infrastructure. The framework specifies a three-gate schema for regulatory compliance verification, formal structural verification, and human oversight attestation, including field-level specifications, conformance rules, controlled vocabularies, and programmatic dependencies. Additional topics include PCCP integration, continuous learning governance, biomedical concept verification via the BiomedicalConceptSurrogate trap, multi-jurisdictional interoperability, and audit trail architecture. Companion data dictionary included. Version 1.0 Working Draft — explanatory narrative sections in progress. Builds upon Thompson, S. (2026). Toward a Regulatory Validation Framework for AI-Assisted Clinical Trial Activation and Execution. NexTrial Dispatch, March 2026.