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. Official Journal of the European Communities 1-5-2001, L 121/34–44.
2. Legislative Decree no. 211 of 24th June 2003. Transposition of Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for clinical use. Ordinary Supplement of Italian Official Journal no. 184 of 9/8/2003.
3. Ministerial Decree 17th December 2004. Prescriptions and conditions of a general nature referring to the conduct of clinical trials of medicines with special reference to those designed to enhance clinical practice as an integral part of health and medical care. Italian Official Journal no. 43 of 22/2/2005.
4. Ministerial Decree 21st December 2007. Directions for submitting the request for authorisation of a clinical trial on a medicinal product for human use to the Competent Authority, for communicating substantial amendments, for declaring the end of the trial and for the request of an opinion to the Ethics Committee. Ordinary Supplement of Italian Official Journal no. 53 of 3/3/2008.
5. Impact of recent legislative bills regarding clinical research on Italian ethics committee activity;Porcu;J Med Ethics,2008