After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of observational studies with medicinal products for human use in the spanish clinical trials registry, as we mentioned in a previous post.
Thus, the AEMPS with the aim to facilitate this process has developed the platform GESTO and has published guidelines and instructions which explain how it works.
Within 15 days after the start of the study, it will be mandatory to apply for registration on this platform, with only the favourable opinion of the ethics committee being necessary for the AEMPS to approve the application.
In addition, it is important to note that both positive and negative results should be published within 1 year from the end of the study or within 30 days of publication in a journal.
Information related to instructions and user guidelines for the GESTO platform can be found at the following links:
https://gesto.aemps.es/gesto/documentos/gesto-guia_rapida.pdf
