The Fundamentals of Clinical Research by P Michael Dubinsky

The Fundamentals of Clinical Research by P Michael Dubinsky

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

P. Michael Dubinsky has more than forty years of experience in the field of GxP quality and compliance in government and industry. He has worked with the FDA and as a regulatory consultant for private corporations. He was also an Instructor in the areas of clinical trial compliance, regulatory audits, and quality at the University of California Berkeley Extension Programs.

Karen A. Henry has worked as a clinical research professional since 1990. She has expertise in regulatory medical writing, standards and processes, trial management and monitoring, biostatistics, and data management. She is also a Lead Instructor for the Certificate Program in Clinical Research Conduct Management at the University of California Berkeley Extension Programs.

SKU	Unavailable
ISBN 13	9781118949597
ISBN 10	1118949595
Title	The Fundamentals of Clinical Research
Author	P Michael Dubinsky
Condition	Unavailable
Binding Type	Hardback
Publisher	John Wiley & Sons Inc
Year published	2022-02-01
Number of pages	544
Cover note	Book picture is for illustrative purposes only, actual binding, cover or edition may vary.