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Barnett International's industry-leading GCP 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. The completely updated and expanded 2015 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, Canada, and China, as well as 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. * *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
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Anne Blanchard, Blanchard & Associates, LLC (Latin America) * Paula Valeria Casasco, PiCRIS LLC (Latin America) * Bobby George, PhD, CCRA, Reliance Life Sciences, Pvt Ltd. (India) * Linda Houle, Linda Houle and Associates (Canada) * Xiaoshun Hong, Professor and Deputy Director of Information Center, China Food and Drug Administration (China) * Earl Hulihan, Earl W. Hulihan Consultancy, LLC (USA) * Allan Johansen, a3GCP Consulting (Australia and New Zealand) * Daniel Liu, Ph.D., Chief Scientific Officer, Beijing Clinical Service Center (China) * Joyce Elaine Marinho, CCRP, COO, Blanchard & Associates, LLC (Latin America) * Munish Mehra, PhD, Tigermed (USA) * Sandra SAM Sather, Clinical Pathways Research (USA) * Chana Sternberg, Chana Sternberg Consultancy, Ltd. (Israel) * Teri Stokes, PhD, GXP International (USA) * Dmitry Vorobiev, MD, Ph.D., MRQA, Clinical Trials Audits and Quality Consulting (Russia) * Beat Wilder, PhD, Widler & Schiemann, (Switzerland) *Review:
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
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