Declaration of Helsinki

    World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18^th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the:
29^th WMA General Assembly, Tokyo, Japan, October 1975
29^th WMA General Assembly, Venice, Italy, October 1983
41^th WMA General Assembly, Hong Kong, September 1989
48^th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52^th WMA General Assembly, Edinburgh, Scotland, October 2000
53^th WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added)
55^th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added)
59^thWMA General Assembly, Seoul, October 2008

    Direttiva 2005/28/CE

    Direttiva 2005/28/CE della Commissione dell’8 aprile 2005 che stabilisce i principi e le linee guida dettagliate per la buona pratica clinica relativa ai medicinali in fase di sperimentazione a uso umano nonché i requisiti per l’autorizzazione alla fabbricazione o importazione di tali medicinali.
Gazzetta ufficiale dell’Unione europea L 91/13 del 9 aprile 2005

    Directive 2005/28/EC

    Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
Official Journal of the European Union L 91/13 of 9 April 2005

    Direttiva 2001/20/CE

    Direttiva 2001/20/CE del Parlamento Europeo e del Consiglio del 4 aprile 2001 concernente il riavvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati membri relative all'applicazione della buona pratica clinica nell'esecuzione della sperimentazione clinica di medicinali ad uso umano.
Gazzetta ufficiale delle Comunità europee L 121/34 del 1° maggio 2001
(recepita nell’ordinamento italiano con il decreto legislativo 24 giugno 2003, n. 211, pubblicato nel S.O. n. 130/L alla G.U. n. 184 del 9 agosto 2003)

    Directive 2001/20/EC

    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 L 121/34 of 1 May 2001

    ICH Harmonised Tripartite Guideline, December 2000

    ICH Harmonised Tripartite Guideline, December 2000
Guidance for Industry - E11 Clinical Investigation of Medicinal Products in the Pediatric Population

    FDA, Guidance for Institutional Review Boards, Clinical Investigators and Sponsors

    FDA, Guidance for Institutional Review Boards, Clinical Investigators and Sponsors
Exception from Informed Consent
Requirements for Emergency Research
(Draft guidance released for comment on March 30, 2000)

    ICH Harmonised Tripartite Guideline, 24 June 1993

    ICH Harmonised Tripartite Guideline, 24 June 1993
Studies in Support of Special Populations: Geriatrics