The Clinical Audit in Pharmaceutical Development

ISBN-13: 9780824703097 / Angielski / Twarda / 1999 / 216 str.

Michael R. Hamrell; Hamrell Hamrell; Michael Hamrell

Opis

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.

Spis treści

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

O autorze

Michael R. Hamrell