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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

P

Potential risk

An untoward occurrence for which there is some basis for suspicion of an association with…

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P

Personal Data

Any information relating to an identified or identifiable individual; an identifiable person is someone who…

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