The CRA's Guide to Monitoring Clinical Research
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. <P>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. <P>Book topics: <P>- Preparing for a study and selecting investigators <br> - Obtaining and monitoring informed consent <br> - Preparing for a monitoring visit <br> - Recruiting and retaining study subjects <br> - Conducting adverse event and safety monitoring <br> - Preparing for audits and detecting fraud