Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition, 2nd Edition (Hardback) book cover

Clinical Research Coordinator Handbook

GCP Tools and Techniques, Second Edition, 2nd Edition

By Deborah Rosenbaum, Michelle Dresser

CRC Press

348 pages

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Hardback: 9781574911237
pub: 2001-10-01
Currently out of stock
eBook (VitalSource) : 9780429134203
pub: 2015-05-06
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This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. With current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently.

Table of Contents

Overview of Clinical Research. FDA Regulations and Good Clinical Practice Guidelines. The Study: Planning Stages and Commencement. Interactions with the Sponsor. Interactions Within the Institution; The Role of the Study Subjects. Data Management: Adverse Events. Investigational Agent Management and Inspection of Clinical Research Sites.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology