Good Clinical Practice: A Question & Answer Reference Guide, May 2012

Newly updated and expanded for 2012, this industry-leading GCP training and reference guide answers approximately 800 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP standards for drugs and biologics. While continuing with a U.S./FDA focus, this innovative reference guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, India, Latin America and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards. With the completely updated and expanded 2012 guide, there are 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;
200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments;
Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US, such as Canada, Latin America, India, and Eastern Europe. In one pocket handbook, you'll have authoritative answers to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips: * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA* Inspections * Investigational Drug Accountability, Administration, and Labeling * Now includes a new section on GCP in Latin America! * Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source! New in 2011: Need-to-know information related to the March 2011 updated version of the FDA s compliance policy guide manual (CPGM) 7348.810, which reveals the agency s goals and specific procedures for FDA field investigators in conducting, sponsor/monitor/CRO inspections. 60+ pages of all-new Q&As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment. A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs. Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments.

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

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