Good Clinical Practices Question and Answer Guide 2014 (Electronic Edition) - $75.95
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.
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
2014 Expert Advisory Panel:
- Anne Blanchard, Blanchard & Associates (Argentina)
- Bobby George, PhD, CCRA, Reliance Life Sciences, Pvt Ltd. (India)
- Linda Houle, Linda Houle and Associates (Canada)
- Earl Hulihan, EW Hulihan and Associates (USA)
- M. Joseph Mardesich, Quality Compliance Consulting, Inc. (USA)
- Munish Mehra, PhD, Quantum Biopharma (USA)
- Jules Mitchel, PhD, Target Health Inc. (USA)
- James Nickas, BioMarin Pharmaceuticals (USA)
- Sandra “SAM” Sather, Clinical Pathways Research (USA)
- Teri Stokes, PhD, GXP International (USA)
- Dmitry Vorobiev, M.D., Ph.D., MRQA, Clinical Trials Audits and Quality Consulting (Russia)
- Beat Wilder, PhD, Widler & Schiemann, (Switzerland)
Read Dr. Teri Stokes - June Blog Post
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:
- An internet connection, user name, and password are required, and will be established during the ordering process.
- Your individual purchase includes access to one computer. Once you access the eGCP from a computer, you cannot view it on any other computer. If you would like to access the eGCP from multiple computers, you will need to purchase additional copies.
- The eGCP is not available in PDF format.
- Printing, copying, and pasting is not permitted.
- The file cannot be emailed or shared.
- The content of the book is not updated. You will be notified when the 2014 edition is available, which will require a new purchase.
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:
- Bulk purchases may be hard copies only, electronic copies only, or a combination of hard copies and electronic copies.
- For multi-user or bulk purchases, the user name and password will be the same for all users.
- It is the purchaser’s responsibility to distribute and manage group accesses. The purchaser must advise users that they are not to access the e-book on more than one computer, unless the purchaser has purchased enough accesses to allow this.
- Once the purchased number of bulk accesses has been reached, no additional users will be able to access the eGCP. Additional accesses will need to be purchased. It is important that the purchaser advises users that every computer that they access the eGCP on will be counted as an access.
- eGCP is not available for access through corporate web sites or intranets.
- Discount rates are available on bulk purchases.
"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