1. International conference on harmonisation, good clinical practice:consolidated guidelines;Food Drug Administration (FDA);Fed Regist.,1997
2. Directive 2001/20/EC of the Europeanparliament 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;OJ.,2001