1. Good Clinical Practice. Also referred to as: ICH E6: Good Clinical Practice: Consolidated Guideline, CPMP/ICH/135/95. Legislative Basis Directive 75/318/EEC as amended, July 1996, entered into force in January (1997). [On-line]. http://pharmacos.eudra.org/F2/eudralex/vol-3/pdfs-en/3cc1aen.pdf (27 July 2004, date last accessed).
2. Directive 2001/20/EC of the European Parliament and of the Council of 4 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. Official Journal of the European Communities, 1.5.2001, L 121/34-44.