SSDataProtection object
Notification to DP Authority/ Ombudsmann is mandatory
No
Approval/ authorisation required
No
Additional Information
Clinical trials have to comply with section 20 subsection 1 No. 2 MPG and Bundesdatenschutzgesetz (BDSG)/German Federal Data Protection Act .
Notification to EC is required concerning the data protection aspects for all investigations on MD (interventional, observational and registries).
