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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.
- 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