MEASuRE: Metreleptin Effectiveness and Safety Registry

ENCePP Code of conduct

N/A

Data sources

• Data source(s), other:
  At specified data collection points (bi-annual) data will be abstracted from patient medical records and charts and will be entered by the treating physicians or their site staff at centres into a computerized data system using structured electronic Case Report Forms (eCRF).
• Data sources (types):
  Electronic healthcare records (EHR)

  Laboratory tests and analyses

  Non-interventional study

  Other
• Data sources (types), other:
  Product registry

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name (other):
  CDM mapping is performed with data from a disease registry in the EEA, the European Registry for Lipodystrophy (ECLip)

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:
  Edit checks and data cleaning plan ; ; Multi-step quality checks, including programmatic validation rules in the study eCRF and extensive cross-registry data reconciliation with the e disease registry, the European Registry for Lipodystrophy (ECLip), are continuously executed complete to ensure data integrity for regulatory updates.