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. About Barnett’s GCP Q&A Guide: At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are 'best practices' derived from regulations, guidances, and industry standards and practices and not all found in black and white in the regulations. Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continue to represent challenges for the pharmaceutical, biotechnology, and medical device industries. 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
2015 Expert Advisory Panel:
- 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, PhD, 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)
Features of the electronic version include:
- Searchable by keyword, with multiple search parameters and page preview.
- Notes function for personalized documentation.
- Active links to external web sites.
- Internal links from Tables of Contents to specific sections.
- Accessible any time on any internet browser (Internet Explorer, Mozilla Firefox, Safari).
Please read these important technical specifications carefully:
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- The eGCP is not available in PDF format.
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Also available in hard copy. Custom cover and group bulk order discounts available! Call 1-800-856-2556 for more information.
Information regarding bulk access purchases:
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'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
'This book is already a leader among GCP references and one that offers an immediate return for readers.'William Hirschhorn, Drexel University College of Medicine