The CRA's Guide to Monitoring Clinical Research

by Karen E. Woodin

The CRA's Guide to Monitoring Clinical Research , now in its third edition, continues to be a key resource for both novice and experienced CRAs seeking to learn more about the field of monitoring or to better understand their roles and responsibilities as the industry becomes more global and technologically focused. With helpful tips and strategies, checklists, personal experiences, key takeaways and exercises, plus new chapters on clinical trial roles and responsibilities, monitoring for device and biologic trials, globalization of studies, EDC and more, The CRA's Guide is a must-have training and educational tool that you ll refer to again and again.

Topics -A comprehensive review of CRA roles and responsibilities
-Understanding regulations and GCPs
-Study initiation and monitoring plans
-Recruiting and retaining study subjects -The informed consent process
-Conducting adverse event and safety monitoring
-Preparing for audits and detecting fraud
-The future outlook
-Job descriptions and current academic programs
-Devices and Biologics
-Managing Multi-national Trials
-IRBs and Data Safety Monitoring Boards
-Exercises with Answers

Recommended -Novice and experienced CRAs
-Health professionals interested in pursuing a career as a study monitor
-Instructors conducting training and educational programs

664 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.

[Lauren · Rating 2 out of 5]

Too simplified and high level for practical advice on monitoring.

[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.

Update: I passed.