Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT) - Local adaptation in Germany from global umbrella protocol (CLOU064A2402)

Data sources

• Data sources (types):
  Electronic healthcare records (EHR)

  Non-interventional study

  Patient surveys

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 v2.0 and SDTM IG v3.4

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

  after extract-transform-load to a common data model

  after creation of study variables
• Data characterisation details:
  The study will collect participant-level data including demographics, medical history, concomitant medications, and laboratory results along with variables required by the protocol. Data will be captured at baseline and at each scheduled follow-up visit as mentioned in schedule of assessment . Variables will include both categorical (e.g., sex, adverse event categories) and continuous measures (e.g., lab values).; For data collection and quality : The study will collect data in an EDC applications. The forms will checks in place to ensure data quality and completeness. The applicable SOPs will be followed to ensure compliance with data collection and reporting process.