Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections, 2nd Edition

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Madzarevic

Clinical Trials Audit Preparation

A Guide for Good Clinical Practice (GCP) Inspections, 2nd Edition

Madzarevic

$248.95

Hardback

Forthcoming
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English

John Wiley & Sons Inc
07 July 2025

Clinical trials

Summary
Details

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.

By: Madzarevic
Imprint: John Wiley & Sons Inc
Country of Publication: United States
Edition: 2nd ed.
ISBN: 9781119684879
ISBN 10: 1119684870
Pages: 350
Publication Date: 07 July 2025
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Forthcoming