Overview

Details the need for, and stresses 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.

Full Product Details

Author:   Michael Hamrell
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Volume:   v. 104
Dimensions:   Width: 15.20cm , Height: 1.90cm , Length: 22.90cm
Weight:   0.430kg
ISBN:  

9780824703097

ISBN 10:   082470309
Pages:   216
Publication Date:   05 November 1999
Audience:   Professional and scholarly ,  Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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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

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