Data management in Pharmacovigilance

The data management plan describes the activities to be conducted in the course of processing data. The clinical data management system (CDMS) is used for  description of data sources, data handling processes, data transfer formats and process, and quality control procedures to be applied.

Sub Tracks:

  • Quality assurance and clinical data management 
  • Data management in epidemiology  and pharmacoeconomics
  • Sources of reports 
  • Triage of reports 
  • Safety update reports and annual update reports 

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