The CRA's Guide to Monitoring Clinical Research

The CRA's Guide to Monitoring Clinical Research by Woodin, Karen E., Ph.D.. paperback edition. ISBN: 9781930624375.

The CRAs 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 CRAs 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 topics: - 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