Aggregate reports

Reports of a set of cases, meant for regulatory authorities.

  • Annual Safety Report (ASR): In clinical trials, an annual report of all newly available safety information. An ASR includes a global analysis for all trials with the same Investigational Medicinal Product (IMP).
  • Development Safety Update Report (DSUR): Annual review and evaluation by the sponsor for regulators of all pertinent safety information collected during the reporting period related to a drug, biologic or vaccine under development, whether or not it is marketed.
  • Periodic Safety Update Report (PSUR): Also called PBRER (Periodic Benefit Risk Evaluation Report). This report (internationally agreed format) provides a periodic comprehensive assessment of the worldwide safety, efficacy and effectiveness data of a marketed drug or biological product. It contains a summary of relevant data, a scientific evaluation, and data concerning sales volume, prescription and population exposure.


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