| Stark NJ, Applied Regulations, Third Edition, Clinical Device Group Inc, Chicago, IL. (2002). Perfect bound, illustrated, 270 pages. ISBN 1-889160-02-4. $250 US. |
Regulations and ethics are the backbone of clinical research--without a solid understanding of the fundamentals, your work product may not substantiate desired claims or support marketing applications. Furthermore, in this age of global economics you will get the most value for your dollar if studies meet requirements of both US and Europe. This comprehensive review of US and EU regulations brings them to life with practical case studies, helping you benchmark you company's interpretations against others'. Click for author's notes or to order.
Contents
1. Ethical Foundation of GCPs
2. Close-up: United States
3. Part 812
4. Sea Change in America
5. Import and Export
6. Close-Up: European Union Directive
7. The Standards
8. US & EU Comparison
9. Europe by Exception
10. Declaration of Helsinki
11. Close-Up CIOMS
12. Multi-National Clinical Development Plans
13. Tips for International Trials