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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

A

Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation…

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C

Consent

In order for processing to be lawful, personal data should be processed on the basis…

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