The CRA's Guide to Monitoring Clinical Research :2nd Edition

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9781930624559: The CRA's Guide to Monitoring Clinical Research :2nd Edition
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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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Review:

Karen and JC have done a fabulous job of presenting the entire spectrum of CRA responsibilities on a very concise and understandable format. It's the best CRA book I've seen to date, and I've seen many. I wish I had had this book when I started monitoring. --Joann C. Phillips, R.N., Former President, ACRP; Senior Program Manager, Clinimetrics Research Associates

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Karen E. Woodin; Ph.D.; John C. Schneider
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