The Clinical Audit in Pharmaceutical Development: 1st Edition (Paperback) book cover

The Clinical Audit in Pharmaceutical Development

1st Edition

Edited by Michael Hamrell

CRC Press

216 pages

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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

    About the Editor

    Michael R. Hamrell

    Subject Categories

    BISAC Subject Codes/Headings:
    MED071000
    MEDICAL / Pharmacology
    SCI013000
    SCIENCE / Chemistry / General