The CRA's Guide to Monitoring Clinical Research, Third Edition - Softcover

Karen E. Woodin; Ph.D.; John C. Schneider

3.96

26 ratings by Goodreads

9781930624603: The CRA's Guide to Monitoring Clinical Research, Third Edition

Softcover

ISBN 10: 1930624603 ISBN 13: 9781930624603

Publisher: CenterWatch, 2011

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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

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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.

Review:

Karen's book is full of the roles and responsibilities of CRAs. There is a continual focus on patient safety and GCP. The chapters are broken down into easy to understand, practical and needed skills and how to implement them. I have recommended this book more times than I can count, it is truly a wealth of information! --Carol Radochonski, RN, BS, CCRA Associate Director, Clinical Operations Quintiles

Karen's CRA Guide is my go to resource for all things related to being a CRA. Her extensive experience, expertise and delightful sense of humor really come through in the book. She provides a treasure chest of sample forms, checklists, logs and hints and tips for making the job easier. This book is my bible of how to do the job right. I never go on a monitoring visit without it! --Lauren Kelley Independent CRA

The CRA's Guide to Monitoring Clinical Research has been a treasured guide and reference throughout my clinical research career. As a new CRA, it provided the necessary fodder for my introduction to the correct conduct of monitoring visits and the overall drug development process. I utilized it profusely while prepping for my ACRP CCRA certification and attribute the comprehensive content to ultimately attaining this certification. This is truly a training manual with content that shall never become outdated or irrelevant; the crucial knowledge between its sleeves remains consistent with the regulations as well as the best practice guidelines that remain the cornerstone of the CRA role. --Elizabeth Weeks-Rowe, LVN, CCRA Training and Curriculum Development Consultant

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