For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals...
The Good Clinical Practice: A Quesiton & Answer Reference Guide 2008
Newly updated and expanded for 2008, this industry-leading GCP training and reference guide answers approximately 500 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 US/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, Latin America, Russia and China! 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.
With the completely updated and expanded 2008 guide, read why clinical investigators may have to list clinical research coordinators and other study staff as sub-investigators, why some European regulators (including the Norwegian Medicines Agency) are warning European clinical investigators not to sign the Form FDA-1572, and what citations in FDA compliance letters should tell you about emerging GCP compliance concerns.
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
- 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
Now includes a new section on GCP in Latin America!
Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!
What's New for 2008:
- 100+ pages of new brand new content, plus hundreds of updated Q&As
- 80 new Q&As focused on emerging areas of GCP
- New section on GCP in Latin America
- Revamped section on Patient Confidentiality/HIPAA in Clinical Trials
- Focus on emerging concerns regarding who must be listed as "subinvestigators," clinical investigator supervision of clinical trials, off-site patient visits in clinical trials, and increasing resistance of
- European clinical investigators to sign Form FDA-1572
"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
Approx. 600 pp., 1-882615-86-7