Survey on the collection of data on adverse events related to medicinal products through registries

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Survey on data collection on safety information by registries
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey questionnaire

Population studied

• Short description of the study population:
  N/A
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  500000

Study design details

• Main study objective:
  The objective of the survey is to gather information on the current practice and capability of registries registered in the ENCePP database to collect, manage and share data on adverse events related to medicines. The responses will provide to stakeholders of the regulatory network key information on the use of registry data as part of post authorisation safety studies.
• Data analysis plan:
  The responses to the survey will be extracted from the EU Survey tool into excel and analysed using Excel tools