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

A must-have guide for any professional in the drug manufacturingindustryThe 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 companiesclinical 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 investigatorsand 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 IRBor 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

Preface.Introduction: Background History on Clinical Standards.Glossary.Chapter 1. Good Clinical Practice and Therapeutic ProductDevelopment.1.1 Good Clinical Practice in Clinical Research.1.2 Role of the Sponsor of a Clinical Investigation.1.3 Role of the Institutional Review Board/Independent EthicsCommittee (IRB/IEC).1.4 Roles and Responsibilities of the Clinical TrailInvestigator.1.5 Clinical Trial Protocol and Protocol Amendments.Chapter 2. Therapeutic Products Clinical Development inthe United States.2.1 Drug Discovery.2.2 Preclinical Development.2.3 Clinical Development.2.4 FDA Considerations for Drug Development.2.5 Phase IV, Postmarketing Surveillance and GCP.2.6 Quality Assurance in Clinical Research.2.7 FDA Inspectional Background and Data.2.8 DFA Bioresearch Monitoring Program.Chapter 3. The Inspection Preparation.3.1 Conduct of an Internal GCP Inspection: Quality AssuranceInspection.3.2 Steps to Prepare for the Internal QA Inspection.3.3 The GCP Quality Assurance Unit.3.4 Steps to Prepare for the Regulatory Inspection.3.5 Clinical Investigator Inspections Preparation.3.6 What to Do When an Investigator Site FDA Inspection isAnnounced.3.7 Sponsor's Inspection Preparation.3.8 What to Do When Sponsors FDA Inspector ArriveUnannounced.3.9 The Institutional Review Board Inspections Preparation.3.10 What to Do When an IRB FDA Inspection is Announced.3.11 The Investigator Site Inspection.3.12 Investigator's Responsibilities.3.13 Types of Clinical Investigator Site Inspections.3.14 Inspectional Procedures.3.15 FDA Audit Procedures for Investigative Sites.3.16 FDA Inspections of International Clinical Trial Sites.3.17 The Audit Report and Form.Chapter 4. Analysis of Warning Letters.4.1 Analysis of Warning Letters Issued to ClinicalInvestigators.4.2 An Analysis of Warning Letters Issued to Clinical TrialSponsors.4.3 Analysis of Warning Letters Issued to Institutional ReviewBoards.Chapter 5. Fraud and Misconduct in Clinical Research.5.1 What Type of Data is Falsified?5.2 How is Data Falsified?5.3 Why is Data Falsified?5.4 Who Falsified the Data?5.5 What Can be Done to Detect Fraud?5.6 How Do We Prevent Fraud?Appendix A. Some Answers to the Most Problematic Questions inCompliance.Appendix B. Guidance for Industry--E6 Good ClinicalPractice: Consolidated Guidance.Appendix C. World Medical Association Declaration of HelsinkiEthical Principles for Medical Research Involving HumanSubjects.Appendix D. Nuremberg Code.Appendix E. The Belmont Report: Ethical Principles andGuidelines for the Protection of Human Subjects of Research.Index.