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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.  

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S

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Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious…

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M

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The collection of microbial life (microbiota) that inhabit a specific environment, and include microorganisms as…

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