For CRAs, trial sites, auditors, compliance, legal, and other clinical professionals...
The Good Clinical Practice: A Question & Answer Reference Guide 2006
Newly updated and expanded for 2006, this industry-leading GCP training and reference guide answers well over 400 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drugs and biologics.
While continuing with a U.S./FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, Canada, India, and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards.
In one pocket handbook, 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
Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
FAQ: "How much is this book different than the last edition?"
The May 2006 Edition of Good Clinical Practice features:
- more than 100 pages of entirely new Q&As
- an entirely new section with Q&As regarding GCP in the European Union (EU)
- an entirely new section with Q&As regarding International GCP, including countries such as India, Russia, Canada, and Japan
- updates to 200 existing Q&As based on the latest FDA GCP compliance trend data, recent in-depth interviews with FDA GCP compliance officials, new FDA guidance documents, etc.
View Journal of Clinical Research Best Practices Journal Book Review
"We believe that Good Clinical Practice: A Question & Answer Reference Guide is the most important advance in clinical research education in quite some time. This is truly 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 is an excellent book--in fact, we thought it was so good that we have obtained copies for all our clinical auditors!"
Ralph Monaghan, BA(Mod) U.S. GCP Audit Director Serono, Inc.
"This new reference takes takes all the key areas of uncertainty in GCP interpretation and implementation that we all struggle with and deals with them head on. It should quickly become the GCP reference of choice in the pharma and biotech industries!"
David Hallinan, Ph.D. Vice President, Regulatory Affairs Idenix Pharmaceuticals
"A reference that goes well beyond a didactic of the regulations to provide informed, practical analysis and advice on both long-discussed as well as important emerging GCP-related issues. An excellent resource for both novice and advanced-level professionals who are actively involved in clinical investigations."
-Joy Littlejohn Regulatory Auditor Alexion Pharmaceuticals, Inc.
"A unique, scenario-based approach that addresses the most important and difficult GCP-related issues and gray areas that we all confront on a daily basis. An extremely useful text that uses a question-and-answer format to explore the depths and breadth of GCP standards. Already a leader among GCP references and one that offers an immediate return for readers."
William Hirschhorn Director, Office of Clinical Trials and Research Quality Improvement Temple University
"I have been involved in drug development for over 20 years and feel that this book should be mandatory for every person involved in clinical research."
Munish Mehra, PhD, Managing Director, Global Drug Development Experts
"This book is excellent. It is comprehensive, authoritative, readable and easy to dip into... Unless you already know all there is to know about GCP, we recommend that you buy this book."
Graeme Scott, Anjo Strik & Jean Saint-Pierre, The Quality Assurance Journal for Pharmaceutical, Health and Environmental Professionals
May 2006, 586 pp., 1-882615-78-6 $39.95