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Glossary

Data Protection Representative (DPR)

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The DPR is the EU representative of non- EU Sponsors that are not established in the EU (do not have an affiliate) and process sensitive data during clinical trials. DPR is mandatory for every non-EU sponsor conducting clinical trials within the European Area.

Other glossary definitions

M

Medical Device (MDR definition)

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer…

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A

Anonymization

The process of rendering data into a form which does not identify individuals and where…

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