1. Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC Chapter 9. http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm and Amendments. Available at: http://www.fda.gov/opacom/laws/default.htm#amendments. Accessed September 17, 2007.
2. Code of Federal Regulations – Title 21, parts 50 and 56; Title 45, part 46.
3. The Belmont report: ethical principles and guidelines for the protection of human subjects of research;National Comission for the Protection of Human Subjects of Biomedical and Behavioral Research,1979
4. International Conference on Harmonization. Available at: http://www.ich.org. Accessed September 17, 2007.
5. The national impact of clinical cooperative group trials for pediatric cancer;Murphy;Med Pediatr Oncol,1995