Clinical Trial Audits & Inspections Explained: Ultimate Guide to Compliance, Readiness, and Best Practices Mastering Clinical Trial Audits & Inspections: Compliance-Ready Guide for Sponsors, CROs, and Investigators Introduction to Clinical Trial Audits and Inspections Clinical trial audits and inspections are formal evaluations conducted to verify that trials are performed in compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards. Inspections may be performed by regulatory authorities such as the FDA, EMA, CDSCO, and other agencies, while audits are usually internal or sponsor-driven activities. Both audits and inspections aim to protect participant safety, ensure data integrity, and verify regulatory…