López Martínez, María del Valle http://orcid.org/0000-0003-3548-938X
Pareja Román, Javier
Jiménez Hernández, María Dolores
Maestu Unturbe, Ceferino
Ramírez-Castillejo, María del Carmen
Article History
Accepted: 17 July 2020
First Online: 22 July 2020
Compliance with Ethical Standards
:
: On January 13, 2016, Royal Decree 1090/2015 of December 4, which regulates clinical trials with drugs, the Ethics Committees for Drug Research and the Spanish Registry of Clinical Studies entered into force. This regulation aims to adapt to Regulation (EU) 536/2014 of the European Parliament and of the Council of April 16, 2014, on clinical trials of medicines for human use, which will be fully applicable in October 2018. In order to be able to continue carrying out the evaluative activity that it carried out up to that moment on clinical trials, it adhered to the Memorandum of Collaboration with the Spanish Agency for Medicines and Health Products (AEMPS) to act as the Research Ethics Committee with medicines (CEIm).At the beginning of the study, All participants provided written informed consent
: The authors declare that they have no conflicts of interest.
: All authors consented.