The CRA's Guide to Monitoring Clinical Research
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About this book
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
