1. Guideline for Good Clinical Practice E6(R1), 1996
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
2. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Biomedical Research Involving Human Subjects,2002
3. The Declaration of Helsinki,1996
4. European Clinical Trials Directive 2001/20/EC
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF
5. Guidance for Industry, Premarketing Risk Assessment, 2005
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126958.pdf