The future Royal Decree will be applicable to all observational studies with medicinal products for human use defined in Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, Research Ethics Committees with medications and the Spanish Registry of Clinical Studies, and that are carried out in Spain.
As new features to be highlighted is the use of a nomenclature closer to the reality of the field of research whose examples are:
- definitions of the beginning or end of the study, pseudonymization, substantial modification of the protocol, protocol;
- the application of the definitions provided for in article 2 of Royal Decree 1090/2015 – among which are the definition of adverse reaction, usual clinical practice, promoter, principal investigator or informed consent – and
- definitions regarding the Post-authorization security studies and the risk management plan included in Royal Decree 577/2013 regulating the pharmacovigilance of medicines for human use.