1. 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;J Eur Commun,2001
2. Clinical research: a European Union directive;Lemaire;Intensive Care Med,2002
3. Impact of the European Clinical Trials Directive on academic clinical research;Baeyens;Med Law,2004
4. 4 European Commission. Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use. 2006. Available at http://www.ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/12_ec_guideline_20060216.pdf (last accessed: 15 January 2008).
5. 5 43 Federal Register 56177. Fed Regist 1981; 46: 8365-92. Available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm (last accessed 16 January 2008).