A comparative observational study to evaluate the safety and effectiveness of Xromi® (hydroxycarbamide oral solution 100mg/ml) for the prevention of vaso-occlusive complications of sickle cell disease in children under 2 years of age. [PRECISE PASS]

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  All data will be collected by the investigational team in participating sites from clinical records obtained as part of participants’ routine clinical practice.
• Data sources (types):
  Electronic healthcare records (EHR)

  Laboratory tests and analyses

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:
  Yes
• Data characterisation moment:
  after data extraction
• Data characterisation details:
  All data is directly collected and standardized in a single EDC system, no CDM mapping required.; Conformance checks will be performed within the EDC to ensure all data entries follow predefined formats, definitions & coding conventions established at the start of the study.; Completeness checks will be configured within the EDC system to flag any missing or incomplete fields during data entry. The system will enforce completeness checks for critical data elements to ensure no key information is omitted.; Stability checks will involve regular monitoring and validation rules to ensure data consistency & accuracy over time in the participant EDC records. ; Logical consistency checks will be implemented in the EDC to identify and flag data entries that do not logically align (e.g., ranges).; Data characterization will be performed to establish baseline metrics on data quality to ID initial quality issues (e.g. completeness, conformance, ID outliers) & inform ongoing data quality assessments.