SSDataProtection object

Notification to DP Authority/ Ombudsmann is mandatory

Yes

Data Protection Authority/ Agency - Contact Details

Danish Data Protection Agency

Phone

+45 3319 3200

Web address

http://www.datatilsynet.dk/english/

Country

Denmark (DK)

Additional Information

Clinical trial on IMP shall also be notified to the Danish Data Protection Agency (according to the Act on Processing of Personal Data).
This may take place at the same time as the application to the CA.
More information on notification requirements can be obtained by the Agency.

If information from patients' records is to be used – in register research projects without the use of biological material – an application for such approval shall be submitted to the DKMA.

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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