Alofisel-5003: An Observational Post-Marketing Registry on the Effectiveness and Safety of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistulas (INSPIRE)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Prospective patient-based data collection, Baseline clinical and treatment information, and effectiveness and safety data (including magnetic resonance imaging MRI reports) will be collected retrospectively, up until the date of entry into the registry, when a patient has been treated before the registry is available to them or prior to consent, but consent has since been provided for participation.

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