The CRA's Guide to Monitoring Clinical Research

by John C. Schneider, John C. Schneider

The CRA's Guide to Monitoring Clinical Research is a valuable and practical educational resource for the individual readers and for group and staff training programs. Written by Karen E. Woodin, Ph.D., and John C. Schneider, this 400+ page CE-accredited book is an ideal resource for novice and experienced CRAs, as well as professionals interested in pursuing a career as study monitors. The CRA's Guide explains the role and responsibilities of a CRA, informs readers of the history of the regulations, explains in detail the research process and describes the regulations and GCPs that govern clinical research. Book - Preparing for a study and selecting investigators
- Obtaining and monitoring informed consent
- Preparing for a monitoring visit
- Recruiting and retaining study subjects
- Conducting adverse event and safety monitoring
- Preparing for audits and detecting fraud

448 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.