SSDataProtection object
Notification to DP Authority/ Ombudsmann is mandatory
No
Approval/ authorisation required
Not specified
Additional Information
The participant in a clinical trial shall be informed of the purpose and scope of the recording and use of personal data, especially medical data. Further details concerning data protection are listed in section 40 subsection 2a AMG and the Bundesdatenschutzgesetz BDSG) - German Data Protection Act (see also the unofficial English version published in the Federal Law Gazette)
