In the context of clinical trials conducted within the European Union (EU), the Data Protection Representative (DPR) is the designated representative of non-EU sponsors who do not have a physical establishment or affiliate within the EU but process sensitive data as part of their clinical trial activities within the European Area.
The presence of a Data Protection Representative strengthens data protection practices and accountability for non-EU sponsors conducting clinical trials within the EU. It provides reassurance to trial participants and regulatory authorities that data privacy is a priority during the research process. By fulfilling its role, the DPR helps maintain trust in the research community and ensures that the rights and privacy of trial participants are protected in accordance with EU data protection laws.
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