The CRC's Guide to Coordinating Clinical Research, Second Edition

by Karen E. Woodin, Ph.D., Cheryl Rosenfeld (Editor)

Overview

The CRC's Guide to Coordinating Clinical Research has been one of the foremost training tools and reference guides for novice and experienced coordinators since the first edition was released in 2004. Now with new chapters on investigational product accountability, device and biologics trials and data safety monitoring boards, along with key takeaways and newly added case studies, The CRC's Guide is the most comprehensive resource available for on-site training staffs, professors or individuals interested in a step-by-step approach to coordinating successful clinical trials.

Topics include:
-A comprehensive review of CRC roles and responsibilities
-Understanding regulations and GCPs
-Preparing for a study
-Working with study subjects
-The informed consent process
-Case report forms and EDC
-Study closure
-The future outlook
-Job descriptions and current academic programs
-Adverse Events and Safety Monitoring
-Sample Forms, Checklists and Logs

Recommended for:
-Novice and experienced CRCs
-Health professionals interested in pursuing a career as a study
coordinator -Instructors conducting training and educational programs

Product Details

BN ID:	2940148659945
Publisher:	CenterWatch
Publication date:	07/05/2011
Sold by:	Barnes & Noble
Format:	eBook
Pages:	611
File size:	2 MB

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. She is the author of The CRA's Guide to Monitoring 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.

Editorial Reviews

As a clinical research professional with 20-plus years of experience, I feel this book should be a required tool for all new and experienced coordinators. This is the most practical tool for clinical research instruction I have ever seen. Dr. Woodin does an excellent job highlighting and thoroughly elucidating all the components needed to coordinate a research study in an efficient and compliant way. Anyone working in the field of clinical research would benefit greatly from reading this guide.

Borgess Research Institute - Julie Bouma