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

by Karen E. Woodin, John C. Schneider, Sara Gambrill (Editor)

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
*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.

454 pages, Paperback

First published January 1, 2003

Reviews

[Toni Snideman]

it's similar to another research book i've read. but while it has a lot of the same information, from a statistics/general inquiry standpoint, i learned a lot of things i didn't know before.

[Veronica G · Rating 3 out of 5]

This book is not riveting. It is also not terrible. It’s actually quite useful for my job. I learned a lot. The chapters included all they needed and not too much extra stuff. I flagged a lot of things to go back to and I’ll take my CCRA test with ACRP soon. I’ll let you know how it goes.

[Lauren · Rating 2 out of 5]

Too simplified and high level for practical advice on monitoring.