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Clinical Trials Audit Preparation

A Guide for Good Clinical Practice (GCP) Inspections

Vera Mihajlovic- Madzarevic

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Naturwissenschaften, Medizin, Informatik, Technik / Chemie


A must-have guide for any professional in the drug manufacturingindustry The Good Clinical Practice (GCP) audit is a tedious butnecessary exercise that assures that all parties do their jobproperly and in compliance with the applicable FDA code.Clinical Trials Audit Preparation demystifies the auditprocess for all parties involved, including clinical researchsponsors, clinical investigators, and institutional reviewboards. This book provides a step-by-step explanation of the FDA auditprocedures for clinical trials and of how pharmaceutical companies,clinical investigators, and institutional review boards shouldprepare for regulatory audits. The book emphasizes the processesand procedures that should be implemented before a clinical auditoccurs, making this an imperative guide to any professional in thedrug manufacturing industry, including drug manufacturingcompanies, regulatory affairs personnel, clinical investigators,and quality assurance professionals. Among the topics discussed: * Good Clinical Practices and therapeutic product development inclinical research * The roles of the sponsor of a clinical investigation, the IRB,or independent ethics committee * The roles and responsibilities of the clinical trialinvestigator * The inspection preparation * The Audit Report and the Form 483 * Warning letters issued to clinical investigators and clinicaltrial sponsors and their impact on product development


(Journal for Clinical Studies, 1 November 2010)
"To help the reader, in addition to the detailed and meticulous discussions in the book's five chapters, appendices provide ready access to fundamental literature . . .Clinical Trials Audit Preparation is recommended to readers, and receives the JCS Library Award."
(Journal of Clinical Research Best Practices, 6 June 2011)
"Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections" is a comprehensive manual for avoiding inspections, preparing for inspections, and being inspected. It is also a useful guide for inspectors."
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Qualitätssicherung, Qualitätssicherung in der Chemie, Drug Discovery & Development, Pharmazeutische Statistik, Chemistry, Pharmaceutical Statistics, Statistik, Wirkstoffforschung u. -entwicklung, Chemie, Quality Assurance, Klinische Studien, Statistics