Good Clinical Practice Fundamentals: A Comprehensive Guide

By P. Michael Dubinsky, this book provides a practical approach to the application of Good Clinical Practice (GCP) fundamentals in clinical trials. It delves into the roles and responsibilities involved in planning, executing, and analyzing these trials, offering insights into the design of quality into clinical trial planning.

The book covers a wide range of topics including regulatory, scientific, administrative, business, and ethical considerations that are essential for successful clinical trials. It also includes end-of-chapter questions and answers to check learning and comprehension, making it an invaluable resource for professionals in the field.

Charts and visual summaries are provided throughout the book, allowing readers to cross-reference details in relevant chapters easily. Furthermore, a companion website offers supplemental training resources, enhancing the learning experience and providing ongoing support.

Key Features:

• Practical application of GCP fundamentals
• Insights into roles and responsibilities in clinical trial planning, execution, and analysis
• Covers regulatory, scientific, administrative, business, and ethical considerations
• End-of-chapter questions and answers for learning and comprehension
• Visual summaries and charts for easy reference
• Companion website with supplemental training resources

Publication Details:

Published by Wiley on December 29, 2021, this book is available in English. The ISBNs are 9781118949597 and 9781118949603, making it easily accessible for those interested in advancing their knowledge in clinical trials and GCP.