Legislations Law 5395, General Health Law, Articles 64-68 (1973) (Spanish)
Regulations
CONIS: Executive Decree No: 31078-S (2003) (Spanish) CCSS: Regulation of Clinical Investigation in the Assistance Services of the Social Security Fund (2005)
Guidelines (CONIS):
Ethical and Legal Principles Duties and Responsibilities of the National Council on Health Research, of Investigators, and of the Sponsor Structure and Functioning of the Committee Network Design of the Research Protocol Requirements for the Submission of a Research Protocol Informed Consent Approval and Follow-up of a Research Project Sanctions Guidelines for Good Clinical Practice (1996) Protocol for Clinical Trials
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