TARGET-EU: Effectiveness of BNT162b2 mRNA COVID-19 vaccine in healthy individuals or with stable pre-existing medical conditions against SARS-CoV-2 infection

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  The Valencia Health System Integrated Database
• Data sources (types):
  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  ConcepTION CDM
• CDM website:
  https://www.imi-conception.eu/
• CDM release frequency:
  6 months

• CDM version:
  2.2

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation details:
  The feasibility assessment for this case study, detailed in the appendix of the study protocol, was conducted as part of the broader TARGET-EU feasibility assessment (EUPAS1000000791). ; ; Data source suitability was evaluated using a structured framework based on the EMA data quality framework, assessing system characteristics, data quality, and fitness for the research question. ; ; The Clinical Practice Research Datalink (CPRD) and The Valencia health system integrated database (VID) were selected as data sources for this study because they offer large, high-quality, population-based electronic health records with national coverage in the UK and Spain, respectively. ; ; Both sources provide the required data elements to operationalize the study design, including demographics, diagnoses, prescriptions, laboratory test results, hospitalizations, and mortality data. In addition, both databases have previously been used in studies of vaccines effectiveness and safety.

Data characterisation details

CS1_Feasibility_Assessment.pdf