Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting

ENCePP Code of conduct

No

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

SIGNED - Declaration of Interests

Composition of steering group and observers

Study Scientific Committee

Signed code of conduct

2014-0029_ Declaration on Compliance_SDPP-7761

Signed code of conduct checklist

2014-0029_CoC Checklist_SDPP-7761

Signed checklist for study protocols

2014-0029_Protocol Checklist_SDPP-7761 r

ENCEPPChecklistForProtocols_20160924_signed

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  THIN® (The Health Improvement Network®)
• Data source(s), other:
  Office for National Statistics (ONS) Mortality statistics, Clinical audit databases managed by the National Institute for Cardiovascular Outcomes research (NICOR): including the Myocardial Infarction National Audit Program (MINAP) and Cardiac Rhythm Management database
• Data sources (types):
  Administrative data (e.g. claims)

  Electronic healthcare records (EHR)

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