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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

S

Serious (Public) Health Threat

Any event type, which results in an imminent risk to the study population of death,…

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D

Device Deficiency

Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety, or…

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