Being prepared for a good clinical practice (GCP) inspection requires ensuring compliance with regulations, maintaining data integrity and prioritizing patient safety. With the introduction of the ICH E6 R3 draft guidelines, a new risk-proportionate approach emphasizes the importance of processes aligned with trial design and execution.
Understanding GCP Inspections: Regulatory authorities expect organizations to be inspection-ready at all times, whether the inspection is announced, unannounced or part of the marketing authorization approval process. Inspections aim to verify compliance with GCP and other regulations, ensuring trial participant safety and data reliability.
Key Changes with ICH E6 R3: The new guidelines introduce principles around data governance, emphasizing the management of data integrity, traceability and security. They highlight the need for risk assessment processes to be embedded in trial protocols, requiring a proportionate approach based on the level of risk associated with each trial.
To ensure compliance, organizations should focus on developing robust risk management programs, implementing consistent risk-based approaches throughout the trial lifecycle and conducting audits and mock inspections to identify potential risks and prepare teams.
Inspection Challenges and Solutions: Common inspection findings often include issues related to data governance, documentation discrepancies and inadequate oversight. Addressing these requires effective collaboration between sponsors, service providers/vendors, and investigator sites, as well as a continuous commitment to refining processes.
Preparation for GCP inspections is an ongoing journey. While inspections can be perceived as daunting, they drive organizations to strengthen compliance and improve trial conduct. Embracing the principles outlined in the ICH E6 R3 draft can lead to better risk management, enhanced data integrity and more reliable trial outcomes.
Register for this webinar today to learn essential strategies for inspection readiness, with insights on the updated ICH E6 R3 guidelines, risk-proportionate approaches and how to build a robust compliance program.
About the Presenters
Dr. Ernesto Vera-Sanchez, MD, PhD, MPH, Vice President, Department Head GxP Strategy, Allucent
Dr. Ernesto Vera-Sanchez has nearly 20 years of experience as a regulator and an EMA & AEMPS GXP Inspector. His comprehensive knowledge of clinical trial regulations and guidance from EMA/FDA/MHRA/PMDA, as well as his extensive experience in inspection strategy and related procedures, lend to his wide-ranging expertise. Ernesto has led over 400 regulatory inspections at clinical investigator sites, CROs, sponsors and vendors.
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