This book explains, step-by-step, the audit procedures for clinical trials and the process of how to prepare for clinical regulatory audits. It emphasizes the processes and procedures that should be implemented before a clinical audit occurs. This new edition takes into account the changes that have occurred in the last decade, including new regulations and processes introduced by various regulatory authorities FDA, Health Canada, and ICH like the use of artificial intelligence, data collection, and updated regulatory documents that all also affect the inspectional strategies for clinical trials. The author provides an overall guide to clinical trial regulatory compliance and inspectional strategy to lead the industry through the process of the GCP audit, incorporating the most updated rules and regulations in the business.
