Good Clinical Practice: A Question & Answer Reference Guide, May 2011

Newly updated and expanded for 2011, 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 2011 guide, read how the FDA will now be focusing more intently on sponsors' "quality systems" when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. 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.