Clinical trials with drugs

Currently, the conduct of clinical drug trials in Spain is regulated by the Royal Decree 561/1993  , by which the necessary requirements for its realization.

After the establishment of the Spanish Medicines Agency , have issued new instructions are aimed at simplifying administrative intervention multicenter clinical trials, in a document entitled "Instructions for applicants for authorization of clinical trials and product under clinical investigation ( PEI)" .

Conducting a drug clinical trial complies with the content authorized by the Ministry of Health, in which fully define all the characteristics of the trial (rationale, objectives, design, methods, etc.) protocol. The trial protocol shall be drawn at least in spanish, and will include all the basic sections with the content described in Annex 1 .

Clinical trials are conducted respecting the fundamental rights of the person and ethical postulates affecting biomedical research involving human beings, following the contents of the Declaration of Helsinki  and subsequent updates. The Declaration of Helsinki (Declaration of the World Medical Assembly) was the first document proposed criteria and measures to protect the subjects participating in clinical research.