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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

R

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the…

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D

Development safety update report (DSUR)

Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of…

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