European Sickle Cell Disease Cohort – Hydroxyurea – Extension study (ESCORT-HU Extension)

ENCePP Code of conduct

Yes

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

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:
  Data QC is performed in all sites in each country involved in the study. In each site, following an iterative approach, 5% of the participants undergo QC. Each CRF page is reviewed completely (100%) by the Clinical Research Associate for accuracy and completion. If the control is not satisfying (% of error >5%), other 5% of participants undergo QC. Furthermore, regular remote monitoring is performed in order to check missing data, inconsistent data and compliance to the study protocol.