Even though a specific code of conduct and a structured process apply to clinical trials, there are lacking dedicated, specific regulations on protecting the personal data obtained in such trials.
As a result, the processing of patient personal data is subject to general regulation in Poland, which is the Personal Data Protection Act of 29 August 1997, “PDPA”, which Act implemented Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995.
The PDPA implies that a sponsor of clinical trials be a data controller, as the sponsor decides on, cumulatively, (i) purposes of personal data processing, and (ii) techniques/mode of personal data processing. The requirement is confirmed in ongoing legislative work.
A sponsor, however, usually does not actually have the personal data of participants in trials, which is caused by how trials are in practice organized. Firstly, sponsors outsource trials to … Continue Reading ››