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CRA's Guide to Monitoring Clinical Research

CRA's Guide to Monitoring Clinical Research - 2nd edition

ISBN13: 978-1930624559

Cover of CRA
ISBN13: 978-1930624559
ISBN10: 1930624557
Edition: 2ND 08
Copyright: 2008
Publisher: CenterWatch
Published: 2008
International: No

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CRA's Guide to Monitoring Clinical Research - 2ND 08 edition

ISBN13: 978-1930624559

Karen E. Woodin

ISBN13: 978-1930624559
ISBN10: 1930624557
Edition: 2ND 08
Copyright: 2008
Publisher: CenterWatch
Published: 2008
International: No
Summary

The CRA's Guide to Monitoring Clinical Research is a comprehensive and practical educational resource for both the novice and experienced CRA. This newly updated training tool provides essential information on the clinical research process, regulations, role responsibilities, helpful hints and personal experiences. This guide also teaches CRAs to demonstrate how regulations, GCPs and SOPs can be applied to everyday operations of conducting and monitoring clinical trials.

Topics covered include:
*The history behind the regulations
*Clinical study preparation
*The informed consent process
*Adverse events and safety monitoring
*Recruitment, retention and compliance of study subjects
*Errors, misconduct and fraud
*The future of CRAs and more

The CRA's Guide to Monitoring Clinical Research is also recommended for CROs, clinical trial sponsors and investigative sites conducting group or staff training programs.

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