Synopsis
The CRA's Guide to Monitoring Clinical Research, now in its third edition, continues to be a key 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. With helpful tips and strategies, checklists, personal experiences, key takeaways and exercises, plus new chapters on clinical trial roles and responsibilities, monitoring for device and biologic trials, globalization of studies, EDC and more, The CRA's Guide is a must-have training and educational tool that you ll refer to again and again.
Topics include: -A comprehensive review of CRA roles and responsibilities
-Understanding regulations and GCPs
-Study initiation and monitoring plans
-Recruiting and retaining study subjects -The informed consent process
-Conducting adverse event and safety monitoring
-Preparing for audits and detecting fraud
-The future outlook
-Job descriptions and current academic programs
-Devices and Biologics
-Managing Multi-national Trials
-IRBs and Data Safety Monitoring Boards
-Exercises with Answers
Recommended for: -Novice and experienced CRAs
-Health professionals interested in pursuing a career as a study monitor
-Instructors conducting training and educational programs
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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