Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials Series)
By Deborah Rosenbaum, Michelle Dresser
- Publisher: Informa HealthCare
- Number Of Pages: 348
- Publication Date: 2001-10-01
- ISBN-10 / ASIN: 1574911236
- ISBN-13 / EAN: 9781574911237
- Binding: Loose Leaf
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. Using current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently. Chapters include: 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.
Rating: 5
Dresser and Rosenbaum have carefully put together a valuable resource for anyone involved in or considering clinical research. This is a complete guide to performing research for new clinical products that will help prevent many of the pitfalls that are easily encountered in this line of endeavor. The wording is precise and clear and the outline logical and easy to follow. This is the first and arguably best guide for performing accurate and meaningful clinical research. The authors' strong backgrounds in this field validates their methods and guidelines. An essential for the library of anyone involved in clinical research.
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