Post-authorisation study to evaluate the effectiveness of the risk minimisation activities in the treatment of SPAF (Risk minimisation in SPAF)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Physician’s knowledge and recommendations to their patients on appropriate dosing and minimizing the risk of bleeding when treated with Pradaxa® Patients’ understanding of the disease, bleeding signs, what to do in case of bleeding and how to deal with emergency situations.

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