SSDataProtection object
Notification to DP Authority/ Ombudsmann is mandatory
No
Approval/ authorisation required
No
Data Protection Authority/ Agency - Contact Details
AGPD (Agencia Española de Protección de Datos) C/Jorge Juan, 6
Phone
+34 901 100 099
Address
C/Jorge Juan, 6
ZIP/City
28001 Madrid
Country
Spain (ES)
Additional Information
The protection of the data of study subjects is mentioned in Art 1-10 of Royal Decree 1090/2015 and safeguarded by Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal.
Royal Decree 1090/2015 (Article 3d)
Legal framework (on safeguarding the collection, handling, recording, keeping and/or processing of any clinical trial related data and patient files)
National Data Protection Act
Other legislation covering DP related issues
National DP act
Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal
Other applicable regulations (covering DP related issues)
Regulation (EU) 2016/679