Clinical Research

Committee on Ethics of Research

The Córdoba Provincial Research Ethics Committee, accredited to evaluate clinical trials with medicines and research with medical devices (CEIm Provincial de Córdoba), reports to the Andalusian Health Service (SAS). Its headquarters are located at the Reina Sofía University Hospital and its area of influence covers the entire province of Córdoba. Its functions include the evaluation of clinical studies involving medicinal products for human use and medical devices (Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and Royal Decree 1090/2015 of 4 December regulating clinical trials with medicinal products, Research Ethics Committees for medicinal products and the Spanish Register of Clinical Studies), observational studies with medicinal products (Royal Decree 957/2020 of 3 November regulating observational studies with medicinal products for human use), research with medical devices (Royal Decree 192/2023, of 21 March, regulating medical devices), research projects (Law 14/2007, of 3 July, on Biomedical Research) and academic studies (undergraduate and master's theses), ensuring at all times the adequacy of methodological aspects,ethical and legal issues in research involving human subjects or the use of biological samples of human origin.

The corresponding fees have been established for applications for observational studies with medicines, research with medical devices, as well as for substantial modifications and expansion of centres in these same studies. Studies promoted by centres and establishments that are part of the Andalusian Public Health System (SSPA) and research that meets all the criteria of the definition of non-commercial clinical research in RD 1090/2015 may apply for exemption from these fees. This information is contained in the document Information on fees for sponsors of clinical trials involving medicinal products and contract research organisations (CROs).