Synopsis
This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded 2016 guide includes: Over 15 new contributing domestic authors with targeted expertise in QA, Monitoring, Compliance, Site Management and several other core GCP areas. * Dozens of new Q&As, including in-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements. * New questions and answers related to GCP expectations, including risk-based monitoring, electronic informed consent and records, social media, HIPAA, and the role and responsibilities of IRBs. * Completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * Updates to reflect the very latest FDA guidances, regulations, comments, and developments for both drugs and devices. * Updates to information on Australia, Canada, China, India, Israel, Latin America, New Zealand, and Russia. * Insights into FDA's focus on sponsors quality systems and risk-based approaches, especially when GCP compliance issues are discovered at the clinical study site.
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Review
This book should be mandatory reading for every person involved in clinical research. --Munish Mehra, Ph.D., Managing Director, Global Drug Development Experts
Unless you already know everything there is to know about GCP, we recommend that you buy this book. This book is excellent. --Graeme Scott, Anjo Strik, and Jean Saint-Pierre in The Quality Assurance Journal
The book is the most important advance in clinical research education in quite some time... A valuable tool that I recommend every clinical research professional have on their desk. --Lisa Zimmerman, MS, Director of QA and Regulatory Compliance, Duke Clinical Research Institute
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