The Clinical Trials AI Playbook: How Clinical Operations Leaders Run Site Selection, Recruitment & Synthetic Control Arms Under ICH-GCP

Your CRO promised AI-driven site selection. Six months in, three sites haven't enrolled a patient. The protocol amendment is overdue. Sound familiar? Clinical operations is being remade by AI in ways that vendors love to demo and ops leaders have to actually deliver on. Site selection, patient recruitment, synthetic control arms, monitoring — every step has an AI offering, an ICH-GCP question, and a regulator who will eventually want to understand what was done and why. This Playbook is for the clinical operations leader who needs the AI gains without the GCP exposure. Inside: Site feasibility templates with AI-augmented data sources — site historical performance, PI activity (auto-source); investigator-meeting calibration (human-in-loop) Patient recruitment optimization: targeting, screening, consent, retention Synthetic control arm validation frameworks (FDA expectations included) Monitoring plan templates updated for AI-augmented risk-based monitoring ICH-GCP-aligned governance for AI use in trials Vendor evaluation frameworks for clinical AI platforms Inspection readiness: what regulators look for in AI-touched studies Written for: Clinical operations leaders, study managers, CRO program managers, quality leaders in clinical research, and FDA clinical inspectorate liaisons preparing for AI-related findings. About the author: P.Z. Murphy writes The AI Playbook series for regulated professionals.