Physician Investigator Handbook: GCP Tools and Techniques, Second Edition (Paperback) (ISBN-13: 9780367396428)

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.

Author: Deborah Rosenbaum,Fred Smith
ISBN-10: 0367396424
ISBN-13: 9780367396428
Publisher: CRC Press
Language: English
Published: 10/10/2019
Pages: 488
Format: Paperback
Weight: 2.50lbs
Size: 10.90h x 8.60w x 1.20d