SSDataProtection object
Notification to DP Authority/ Ombudsmann is mandatory
No
Approval/ authorisation required
No
Data Protection Authority/ Agency - Contact Details
Bureau of the Commissioner for Patients’ Rights
Phone
+48 22 532 82 50
Address
Ul. Młynarska 46
ZIP/City
01-171 Warsaw
Country
Poland (PL)
Additional Information
The source data are stored in a secure location at the trial site. Access is restricted according to national law. Patients’ consent hast o include statement about access to the data for monitoring, audit and inspection. Electronic froms of documentation have to comply with national legal requirements, including restricted access and security.
Legal framework:
• Act on Patients’ Rights and the Commissioner for Patients’ Rights 6 November 2008 (Dz.U. 2009 nr 52 poz. 417)
• Act of 29 August 1997 on the Protection of Personal Data (en) (unified text: Jounal of laws of 2002 No. 101 item 926 with amendments)