Data sources

Data sources (types)

Other

Data sources (types), other

Data will be collected/extracted from sites based in the UK, US and Spain. The study will involve the abstraction of data from patients’ medical charts by healthcare professionals involved in the care of the patients into a secure eCRF. Sites will be asked to provide eCRFs for all patients which they have access to who meet the inclusion criteria. Sites will be instructed to refer to the patients’ complete medical record whilst completing the eCRF and not to answer any question from memory or that is not listed within the patients’ medical records.
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No