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

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