The GCP Question & Answer (Q&A) Guide - For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals
For the print edition, click here
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What's new for 2012?
Addition of 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
Numerous new Q&As, including questions addressing emerging topics such as the new risk-based approach to monitoring clinical trials, and new changes and information to be provided in informed consent documents
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, such as Canada, Latin America, India, and Eastern Europe
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
State Standards and GCP
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
Barnett’s guide also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
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.
- 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 2013 edition is available, which will require a new purchase.
Information regarding bulk access purchases:
- Bulk purchases may be hard copies only, electronic copies only, or a combination of hard copies and electronic copies.
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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
Editor in Chief: Michael Hamrell, PhD, RAC, RQAP-GCP, President, MORIAH Consultants
Editor Emeritus: Mark Mathieu, PAREXEL International Corporation
2012 Expert Advisory Panel:
Anne Blanchard, Blanchard & Associates (Argentina)
Glenda Guest, NCRA (USA)
Stuart Horowitz, Huron Consulting Group (USA)
Linda Houle, Linda Houle and Associates (Canada)
Earl Hulihan, Medidata Solutions (USA)
John Isidor, Schulman Associates IRB (USA)
M. Joseph Mardesich, Quality Compliance Consulting, Inc. (USA)
Munish Mehra, Quantum Biopharma (USA)
Jules Mitchel, Target Health Inc. (USA)
Raeda Mustafa, Molecule CRO (Jordan)
James Nickas, BioMarin Pharmaceuticals (USA)
Deidra Poucher, Norton Audits, (USA)
Alicia Pouncey, Aureus Consulting (USA)
Ernest Prentice, MD, University of Nebraska (USA)
Sandra “SAM” Sather, Clinical Pathways Research (USA)
Adil Shamoo, MD., University of Maryland (USA)
Teri Stokes, GXP International (USA)
Michael A. Swit, Duane Morris LLP (USA)
Beat Wilder, E. PhD, (Switzerland)
Approx. 750 pp.
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