Source Documentation & ALCOA++ in Clinical Trials: An Inspection-Ready Playbook for Sites and Sponsors 2026
Source Documentation & ALCOA++ in Clinical Trials: An Inspection-Ready Playbook for Sites and Sponsors Building Inspection-Ready Source Documentation Aligned to ALCOA++ Regulatory Foundations and What “Source” Means in Practice Source documentation is the first place where clinical facts are recorded—medical history, consent conversations, eligibility determinations, dosing, adverse events, endpoint assessments, device data, and protocol deviations….