1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 Guidelines. [ http://www.ich.org/LOB/media/MEDIA482.pdf ]
2. Zon R, Meropol NJ, Catalano RB, Schilsky RL: American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol. 2008, 26 (15): 2562-2567. 10.1200/JCO.2007.15.6398.
3. European Parliament: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001. Official Journal of the European Communities. 2001, L121: 34-44.
4. Pharmaceutical Affairs Law. [ http://law.e-gov.go.jp/htmldata/S35/S35HO145.html ]
5. Ministry of Health, Labour and Welfare Ordinance on GCP. [ http://law.e-gov.go.jp/htmldata/H09/H09F03601000028.html ]