SSDataProtection object
Notification to DP Authority/ Ombudsmann is mandatory
Yes
Language of notification
French only
Notification format
Online
Notification fee required
No
Data Protection Authority/ Agency - Contact Details
Commission Nationale de l'Informatique et des Libertés (CNIL)
Phone
+33 153 73 22 22
Fax
+33 153 73 22 00
Address
8 rue vivienne
ZIP/City
75083 Paris cedex 02
Country
France (FR)
Additional Information
Notification is required for interventional and observational investigations on MD (and combination studies with MP).
National DP act
The privacy of participants is protected by the French Data Protection Law (Loi 2004-801) relating to the protection of individuals with regard to the processing of personal data that modifies Act 78-17 of 6 January 1978 on Data Processing, Data Files and Individual Liberties. This law includes provision concerning health data collecting within clinical research (also available in English: French Data Protection Law).
