Physician Investigator Handbook : GCP Tools and Techniques, Second Edition
Book Details
Format
Paperback / Softback
ISBN-10
0367396424
ISBN-13
9780367396428
Publisher
Taylor & Francis Ltd
Imprint
CRC Press
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Oct 10th, 2019
Print length
488 Pages
Weight
1,248 grams
Dimensions
21.90 x 27.50 x 2.90 cms
Product Classification:
Clinical trials
Ksh 13,100.00
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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.
Presenting a broad research perspective, this second edition of a bestseller is a comprehensive guide for physicians conducting clinical research. 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 authors 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.
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