The CRA's Guide to Monitoring Clinical Research, Fourth Edition

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About The CRA's Guide:

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.

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 or clinical research monitors, clinical research managers or other clinical research staff with an interest in study monitoring
  • Health professionals interested in pursuing a career as a study monitor
  • Instructors conducting internal or external training and educational programs

Reader Comments:

“The CRA's Guide 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

“The CRA's 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

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