SSDataProtection object
Yes
No
The Inspector General for Personal Data Protection - GIODO
+48 22 860 70 86
+48 22 860 70 86
ul. Stawki 2
00-193 Warszawa
Poland (PL)
Notification of clinical investigations to GIODO is required for all clinical investigations of MD.
The right for the subject to personal data protection shall be safeguarded according to Art 40 (4.3) and 55 Medical Device Act 2010 and the Act on Patients’ Rights and the Spokesman for the Patients’ Rights 6 November 2008 (Dz.U. 2009 nr 52 poz. 417:
Before obtaining consent, the investigator shall inform the participant, that source documents will be available for monitoring purposes, internal and external audits. The sponsor must archive the documentation of a study for 5 years starting from the beginning of the year after the study was completed unless a contract between the sponsor and the investigator defines a different time period (Art. 37ra. par. 1).
