1. Directive 2001/20/EC of the European parliament and of the council of 04 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;European Parliament.;Official Journal of the European Communities,2001
2. World Medical Association (WMA). Declaration of Helsinki, 52nd WMA General Assembly. 2000 http:www.wma.netepolicy17-ce.html
3. International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). ICH Topics and Guidelines. http:www.ifpma.orgich5.htm