Good Clinical Practice - a Question And Answer Reference Guide

Newly updated and expanded for 2010, this industry-leading GCP training and reference guide answers approximately 700 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 pocket 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. The completely updated and expanded 2010 guide includes: * 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.