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Physician Investigator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials Series)

Name: Physician Investigator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials Series)
ISBN: 9781574911244

Deborah Rosenbaum, Fred Smith

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A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.

Категории:

Medicine

Година:

2002

Издание:

Издателство:

Informa Healthcare

Език:

english

Страници:

482

ISBN 10: