The Clinical Audit in Pharmaceutical Development / Edition 1

by Michael Hamrell

Overview

This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results.
Examines the use of personal computers, the Internet, and third-party organizations to assist in data validation!
Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, The Clinical Audit in Pharmaceutical Development

recommends establishing auditing and quality assurance at the beginning of a clinical study

describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes

outlines the clinical process, from trial design through report writing

compares and contrasts United States and international regulatory statutes

identifies monitoring as the key to guaranteeing high-quality data

focuses on the role of the clinical audit in achieving unity in a multinational study

discusses the worldwide influence of the US Food and Drug Administration audit

analyzes findings from previous FDA clinical audits to reveal trends and future directions

provides guidelines for fraud detection and considers the ramifications of falsified data

and more!
Confirming that all clinical information has been properly collected and reported, The Clinical Audit in Pharmaceutical Development is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

Product Details

ISBN-13:	9780367399337
Publisher:	Taylor & Francis
Publication date:	09/05/2019
Series:	Drugs and the Pharmaceutical Sciences , #104
Edition description:	Reprint
Pages:	216
Product dimensions:	6.12(w) x 9.19(h) x (d)

Table of Contents

Introduction to the Clinical Development Process
Michael R. Hamrell
Statutory Requirements and Regulatory Guidance
Tammala Woodrum, Diana B. Lee, and Jon R. Wallace
Source Documentation: Clinical Auditors' Observations
Vernette J. Molloy and Douglas R. Mackintosh
Quality Assurance in Clinical Trials
Richard Kiernan
Standardizing Quality in International Studies
Marijke Korteweg
Good Clinical Practices and Computers
Tammala Woodrum
Food and Drug Administration Audit
Arthur M. Horowitz
GCP Compliance Assessed by Independent Auditing: International Similarities and Difference
W. Boyachuk and G. Ball
Fraud and Misconduct in Clinical Research
Frank Wells

Appendix: ENGAGE: European Network of GCP Auditors and Other GCP Experts

Editorial Reviews

Reviewer: Cheryl Lynn Nunn-Thompson, PharmD, MBA (University of Illinois at Chicago College of Pharmacy)
Description: This book is a review of global efforts by regulatory agencies and clinical study sponsors to validate and audit clinical study data. Contributors also provide a comprehensive overview of management of quality assurance in clinical trials, Good Clinical Practices (GCP), and management of audit outcomes.
Purpose: According to the editor, the purpose is to "gather the collective expertise of a worldwide group of experts to address the current issues and trends in the validation and auditing or a clinical study." These are worthy objectives, as quality issues in the drug approval process encompass international challenges to build quality assurance into the design of clinical trials. In particular, this is an important book given recent disclosures regarding fraud and misconduct in clinical research; the audit of clinical trial data is important to avoid this problem in future research. The editor has achieved his stated purpose/objectives.
Audience: Although the editor does not specify an audience for this text, it would be suitable for a wide range of individuals involved in either designing or auditing clinical trial data. This would include quality assurance personnel in the pharmaceutical industry or in governmental regulatory agencies, individuals from contract research organizations (CRO), members of institutional review boards (IRB) committees, or clinical investigators. The editor of the text is a consultant in this field; chapters are written by eleven contributors whose expertise appears to be related to the field of quality assurance of clinical trial data. Unfortunately, biographies of these individuals are not provided for the reader.
Features: Overviews of the clinical development process, statutory requirements and regulatory guidance, clinical auditors' observations, quality assurance in clinical trials, standardizing quality in clinical trials, GCP, and computers, Food and Drug Administration (FDA) audits, international assessment of GCP compliance, and fraud in clinical research are all provided in this book. Each chapter contributor provides a general overview of the topic and refers readers to additional sources for more comprehensive and technical information. Each chapter is fairly current in content and minimally referenced; this book does not contain any graphics or tables. An appendix contains a several reference documents.
Assessment: This would be a useful introductory text for individuals involved in the validation and auditing of clinical trial information. The editor provides an international perspective on designing quality into clinical research, covers important sub-topics in the field, and presents the information at a general level.

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