The CRA's Guide to Monitoring Clinical Research, fourth edition, continues to be a vital resource for both novice and experienced CRAs seeking to learn more about the field of monitoring or to better understand their roles and responsibilities as the industry becomes more global and technologically focused. This edition includes helpful tips and strategies, checklists, personal experiences, traveling tips, key takeaways and exercises. With new and updated chapters on the evolving CRA roles and responsibilities, monitoring for device and biologic trials, risk-based monitoring, globalization of studies, EMR, web-driven data collection, the sub-PI role, and more, The CRA's Guide is a must-have training and educational tool that you'll refer to time and time again.

About the Author

Karen E. Woodin earned her M.S. in Applied Statistics at Western Michigan University and her Ph.D. in Epidemiology from the School of Public Health at the University of Massachusetts, Amherst. Dr. Woodin has over 30 years of experience in the pharmaceutical industry, including more than 20 years at The Upjohn Company/Pharmacia (now part of Pfizer), where she worked in the areas of biostatistics, clinical trial operations and monitoring and drug safety. She currently works as an independent consultant specializing in clinical trial operations, good clinical practices (GCPs) and standard operating procedures (SOPs). She works with investigative sites, sponsors and IRBs, and also develops and teaches courses in these areas. As well as co-authoring this book with JC Schneider, she is the author of The CRC s Guide to Coordinating Clinical Research, also published by CenterWatch. Dr. Woodin is a long-time member of the Drug Information Association (DIA) and has served on the DIA board of directors and as chair of the Steering Committee for the Americas. She has also developed and taught courses for DIA. She is a recipient of the DIA Outstanding Service award.

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