CASubmissionFormat object

Format option(s)

Online portal

Online portal

Portal ECM (Ensayos Clínicos con Medicamentos).

Guidance on submission format

The AEMPS website (Section Clinical Trials) provides practical guidance and manuals on the use of the portal ECM and the application modality.
Link for submission: http://www.aemps.gob.es/ (click in “sede electrónica”, to upload the xml file with the protocol)

Applicable national legal framework/ Reference

Related information to the application procedure is described in Royal Decree 1090/2015 (Chapter 5, section 2, Article 21).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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