Data Quality Management and Analysis

Good data quality management in pharmacovigilance can be relied only on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. Quality management consists of quality planning, quality control, quality assurance and quality improvements. The pharmacovigilance data processing cycle starts with data collection and, in computerized systems, data entry; the next step is data storage and maintenance; followed by data selection, retrieval and manipulation.


  • Managing reference data (e.g., drug names, patient IDs)
  • Data Quality Control and Assurance
  • Quality Planning and Improvement
  • Data Safety Monitoring

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