The Clinical Audit in Pharmaceutical Development (eBook, PDF)

Redaktion: Hamrell, Michael

• Format: PDF

Produktbeschreibung

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

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 216
• Erscheinungstermin: 5. November 1999
• Englisch
• ISBN-13: 9781420001266
• Artikelnr.: 54254471

Autorenporträt

Michael R. Hamrell

Inhaltsangabe

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