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Good Clinical Practice: A Question & Answer Reference Guide 2011
Cambridge Healthtech Institute, June 2011, Pages: 750
For CRAs, investigators/sites, auditors, compliance, legal, and other clinical professionals
For the first time ever, this popular reference guide will be available in fully searchable, electronic format!
- Viewable on any web browser (e.g., Internet Explorer, Mozilla Firefox)
- User name and password accessible
- Searchable by keyword, with multiple search parameters and page preview
- Notes function for personalized documentation
- Active links to external web sites
What's new for 2011:
- 60+ pages of all-new Q&As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment.
- A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs.
- Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance.
- 200+ Q&As updated to reflect the very latest FDA guidance, regulations, comments, and developments
While continuing with a U.S./FDA focus, this innovative reference 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, India, Latin America 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.
With the completely updated and expanded 2011 guide, read how the FDA will now be 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.
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!
Reader Testimonials:
'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
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