Types of studies and documentation to be submitted
Data updated as of January 2025
- Clinical trials with drugs regulated by Royal Decree 1090/2015
. - Clinical research with healthcare products regulated by Royal Decree 192/2023, of 21 March, regulating medical devices and by EU Regulation 2017/745 of the European Parliament and of the Council on medical products.
- Observational studies with drugs for human use regulated by the Royal Decree 957/2020 of 3 November 2020, regulating observational studies with drugs for human use.
- Other studies: Clinical trials without drugs or healthcare products, research projects with biological samples, observational studies without drugs, according to the applicable legislation and regulated by Law 14/2007 on Biomedical Research.
- Bachelor’s Theses
In the following links you will find all the information related to the types of studies and documentation to be submitted:
