Patient Experience Data in Non‑Interventional Studies Supporting EMA Marketing Authorisation Applications between 2018 and 2023

Data sources

• Data source(s), other:
  Regulatory documents including assessment reports from the Committee for Medicinal Products for Human Use (CHMP), Risk Management Plans (RMPs), and, where applicable, protocols and assessment reports of post‑authorisation studies.
• Data sources (types):
  Vaccination registry

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Not applicable