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

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Product Description

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.

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

The Physician Investigator Handbook, by Deborah Rosenbaum and Fred O. Smith, is an excellent book for every physician who conducts, or who has ever considered conducting, clinical trials. The book contains practical and useful information about the conduct of clinical trials from the physician's perspective. Physicians will learn, in a clear and concise format, about the facilities and staff required, the investigator's role, compliance with regulations, and how to prepare study budgets and work with the study sponsor and its representatives. This book is an excellent guide to help physicians decide whether to enter the lucrative world of clinical trials. Furthermore, it can save time and money for novice and experienced investigators alike. I highly recommend this book for all physician investigators involved in the conduct of clinical trials. The authors write from experience and pack the book with useful information. What a great investment!

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