A Clinical Trials Manual From The Duke Clinical Research Institute, 2nd Edition, 9781405195157
Paperback
This second edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled.

A Clinical Trials Manual From The Duke Clinical Research Institute, 2nd Edition

Lessons from a Horse Named Jim

$202.78

  • Paperback

    432 pages

  • Release Date

    21 January 2010

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Summary

“The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety al…

Book Details

ISBN-13:9781405195157
ISBN-10:1405195150
Author:Margaret Liu, Kate Davis
Publisher:John Wiley and Sons Ltd
Imprint:Wiley-Blackwell
Format:Paperback
Number of Pages:432
Edition:2nd
Release Date:21 January 2010
Weight:826g
Dimensions:246mm x 172mm x 23mm
What They're Saying

Critics Review

“This is an excellent guide to how to conduct clinical trials of medical devices and biologics in the light of recent regulatory and clinical developments. The roles and responsibilities of institutional review boards and recent developments regarding subject privacy concerns and regulations are well covered. This manual also provides sample forms and worksheets for data management.” (Doody’s, 5 August 2011)

“A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition” is a good introduction to clinical research, primarily from the site perspective. The book gives readers a solid foundation of principles and knowledge.” (Journal of Clinical Research Best Practices, 8 August 2011)

About The Author

Margaret Liu

Margaret Liu is a clinical trials consultant based in Singapore and former manager of the Monitoring Group at the Duke Clinical Research Institute (DCRI).

Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US.

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