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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

Appropriately Reduce (risk)

The reduction of risk to an acceptable level as determined by the manufacturer and regulatory…

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E

Efficacy-Effectiveness Gap

The observed discrepancy between effects of a health intervention in routine clinical practice as compared…

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