The Legal Regulations governing the implementation of clinical trials includes the following documents:

• Royal Decree 223/2004, of 6 February, establishing the requirements for the implementation of clinical trials using medicinal products. Clarifications on the application of the regulations on clinical trials using medicinal products for human use, version of 6 May 2008.
• Order of the 24 October 2006, on the accreditation of Clinical Research Ethics Committees.
• Helsinki Declaration (updated in Seoul 2008), proposal of ethical principles for guiding professionals performing medical research on human beings.
• Law 14/2007 on Biomedical Research
• Royal Decree 1720/2006 of 21 December approving the development of Law 15/99.
• Law 15/1999 on the Protection of Personal Infomation
• Law 29/2006 Guarantee of the rational use of medicinal and health products
• Royal Decree 1344/2007 of 11 October regulating the pharmacovigilance of medicinal products for human use
• Order SAS/3470/2009 of 16 December, guidelines on post-authorisation observational studies for medicinal products for human use.
• Directive 2005/28/CE
• Order SCO/256/2007
• Terminology for clinical trials
• ICH Guide. Harmonised Tripartite Guideline for Good Clinical Practice . European EMEA-ICH .CPMP/ICH/135/95
• EMEA Directive 2001/20/CE