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Glossary

Data lock point (DLP)

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For a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.  

For a periodic benefit-risk evaluation report (PBRER), the date designated as the cut-off date for data to be included in a PBRER, based on the international birth date.  

For a development safety update report (DSUR), the date designated as the cut-off date for data to be included in a DSUR, based on the development international birth date.  

Other glossary definitions

E

Effectiveness

The achievement of desired results under the usual circumstances of health care practice.

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I

Incident for Medical Device (MEDDEV definition)

Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due…

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