Post-authorisation observational safety study to examine the effectiveness of risk minimization measures in place in persons with an Anapen® prescription (PASS 21-08)

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  The source of information for the study will be the data collected by the pharmacist dispensing Anapen® and participants’ self-reported questionnaire.
• Data sources (types):
  Patient surveys

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  No