Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations. This book offers useful information for various standards including Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice. It gives detailed explanations of how to prepare, update, and maintain Standard Operating Procedures and also includes advice on training and development of personnel. This text is ideal for clinical trial monitors and quality assurance personnel in the pharmaceutical industry.

chapter 1|20 pages

In the Beginning There was GLP

chapter 2|38 pages

Before GCP

chapter 3|16 pages

Training in the Regulated Environment

chapter 4|28 pages

Computing in the Regulated Environment

chapter 5|26 pages

QA Activity

chapter 6|20 pages

Beyond Compliance

chapter 7|30 pages

Business Improvement

chapter 8|28 pages

A Summary