Vera Mihajlovic-Madzarevic

Clinical Trials Audit Preparation

A Guide for Good Clinical Practice (GCP) Inspections

• Gebundenes Buch

Produktbeschreibung

All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step by step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits.

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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

Produktdetails

• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 272
• Erscheinungstermin: 8. Juni 2010
• Englisch
• Abmessung: 240mm x 161mm x 19mm
• Gewicht: 505g
• ISBN-13: 9780470248850
• ISBN-10: 0470248858
• Artikelnr.: 27871820

Autorenporträt

VERA MIHAJLOVIC-MADZAREVIC has more than twenty years of experience in scientific and clinical research in the academia and industry. She is the Director of Global Research Pharma Canada. She conducts Good Clinical Practice (GCP) audits for the pharmaceutical, biotech, and medical device industries worldwide in compliance with FDA, Health Canada, and other regulations. She also trains clinical and scientific personnel in GCP and clinical research, leading the Training and Professional Development Programs at the Clinical Research Institute of America (criamerica.com) and the Academy of Applied Pharmaceutical Sciences.

Inhaltsangabe

Preface. Introduction: Background History on Clinical Standards. Glossary.
Chapter 1. Good Clinical Practice and Therapeutic Product Development. 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 Ethics Committee (IRB/IEC). 1.4 Roles and
Responsibilities of the Clinical Trail Investigator. 1.5 Clinical Trial
Protocol and Protocol Amendments. Chapter 2. Therapeutic Products Clinical
Development in the 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 Assurance
Inspection. 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 is Announced. 3.7 Sponsor's
Inspection Preparation. 3.8 What to Do When Sponsors FDA Inspector Arrive
Unannounced. 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 Clinical Investigators. 4.2 An Analysis of Warning
Letters Issued to Clinical Trial Sponsors. 4.3 Analysis of Warning Letters
Issued to Institutional Review Boards. 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 in Compliance. Appendix B.
Guidance for Industry--E6 Good Clinical Practice: Consolidated Guidance.
Appendix C. World Medical Association Declaration of Helsinki Ethical
Principles for Medical Research Involving Human Subjects. Appendix D.
Nuremberg Code. Appendix E. The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research. Index.