The Clinical Audit in Pharmaceutical Development  book cover
1st Edition

The Clinical Audit in Pharmaceutical Development

Edited By

Michael Hamrell

ISBN 9780367399337
Published September 5, 2019 by CRC Press
216 Pages

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Book Description

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.
  • 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

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    Michael R. Hamrell