ABSTRACT
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
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
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
