Good Clinical Practice: A Question & Answer Reference Guide, May 2013

Featuring An All-New Index of Topics!

This industry-leading GCP training and 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. And, in response to popular demand, the 2013 edition features an all-new index, making topic research easier than ever before. The completely updated and expanded 2013 guide includes: * Input from an Expert Advisory Panel including distinguished international GCP experts who have assured that the book contains the most current and up-to-date information on global GCP requirements. * Over 100 new Q&As, including questions addressing key topics such as risk-based approaches to monitoring clinical trials, and new changes and information to be provided in informed consent documents. * Revisions and updates to the section on HIPAA and privacy on this tenth anniversary of the implementation of the law. * Updated information on electronic records and use of EMR in clinical research. * 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. * Updates to information on Latin America, India, Russia, Ukraine, and China, and the addition of GCP information for Canada. Read how the FDA is 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 Barnett s comprehensive guide, 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