The Association of Clinical Research Professionals

Inspection Readiness for Clinical Trials: Managing Inspections with ICH E6(R3) Guidance

​​Inspection readiness is an ongoing commitment to quality, compliance, and effective trial oversight.

This course equips clinical research professionals with practical strategies for preparing for, managing, and responding to regulatory inspections with confidence. Applying ICH GCP E6(R3) principles, learners will explore risk-based quality management, oversight, essential records, data integrity, and quality system practices that support continuous inspection readiness throughout the clinical trial lifecycle. Through real-world examples and scenarios, participants will learn how to prepare for inspections, engage effectively with inspectors, interpret inspection outcomes, and address findings through appropriate corrective and preventive action (CAPA) planning. While the course highlights inspections conducted by the FDA, MHRA, and EMA, the principles apply broadly across regulatory authorities and support inspection readiness for investigators, sites, sponsors, and service providers.​

At the end of this course, participants should be able to:

  • ​​Describe proactive and risk-based preparation strategies for regulatory inspections.
  • ​Identify investigator, site, and sponsor/service provider activities that support inspection readiness throughout a clinical trial.
  • ​Apply quality systems, oversight practices, and data integrity expectations under ICH GCP E6(R3) to support effective inspection readiness.​Recognize common inspection findings and appropriate approaches for responding to regulatory observations and corrective action requirements.​ 

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date