1. Guideline for Good Clinical Practice 2003 http://www.ich.org/LOB/media/MEDIA482.pdf
2. European Community 1995 http://ec.europa.eu/justice_home/fsj/privacy/index_en.htm
3. Italian Law DL196/2003 2003
4. Food and Drug Administration 2003 Fed. Reg. http://www.fda.gov/cder/guidance/5667fnl.htm