Good Clinical Practice: A Question & Answer Rference Guide, May 2014 - Softcover

Softcover

ISBN 10: 0988314479 ISBN 13: 9780988314474

Synopsis

This industry-leading GCP reference guide answers over 1,200 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 2014 guide includes: In-depth analysis from distinguished international GCP experts who address 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 updated information on the role and responsibilities of IRBs. * Revisions and updates to the section on HIPAA and privacy. * Updated information on electronic records and use of EMRs 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. * Many Q&As added regarding clinical trials and GCP for medical devices. * Updates to information on Latin America, India, Russia, Ukraine, Canada, and China, and the addition of GCP compliance and clinical trial requirements for Australia, New Zealand, and Israel. * Insights into how the FDA is focusing more intently on sponsors quality systems and risk-based approaches, especially when significant problems are discovered at the clinical study site, why significant non-compliance is still being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues.

Edition details

• Language: English
• ISBN 10: 0988314479
• ISBN 13: 9780988314474
• Binding: Spiral-bound
• Number of pages: 724