Physician Investigator Handbook: GCP Tools and Techniques, Second Edition, 1st Edition (Paperback) book cover

Physician Investigator Handbook

GCP Tools and Techniques, Second Edition, 1st Edition

By Deborah Rosenbaum, Fred Smith

CRC Press

482 pages

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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.

Table of Contents

Overview and Elements of Clinical Research. The Physician as Investigator. Professional Interactions. FDA Regulations and Good Clinical Practices Guidelines. Investigational Agent Management. Designing a Study and Protocol Development. The Informed Consent Process. Conducting the Study. Monitoring of Clinical Trials. Interactions with the Study Subjects. Adverse Events and Drug Safety. Data Management. The Study Results. Audits of Clinical Research Sites.

About the Authors

Rosenbaum, Deborah; Smith, Fred

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General