A multinational Post-Authorisation Safety Study evaluating real-world treatment in patients receiving Yselty® (linzagolix choline) for moderate to severe symptoms of uterine fibroids - DAISY

Data sources

• Data source(s), other:
  prospective patient medical dossier-based data collection
• Data sources (types):
  Non-interventional study

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  CDISC SDTM
• CDM website:
  https://www.cdisc.org/standards/foundational/sdtm

• CDM version:
  SDTM IG:3.4

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation moment:
  after extract-transform-load to a common data model

  after creation of study variables
• Data characterisation details:
  Data quality Checks will be performed according to internal Standard Operation Procedures which describe the programming and validation of data sets and by using PINNACLE 21 Enterprise version to perform conformance checks of SDTMs and ADaMs against CDISC standards.