Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions

ENCePP Code of conduct

No

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

IV Iron_DoIForms_1_2

IV Iron_DoIForms_1_2_update_5Feb2019

Composition of steering group and observers

IV Iron Steering Committee

Steering Committee List_2019

Signed code of conduct

2017-0046_Declaration_EUPAS20720

Signed code of conduct checklist

2017-0046_Checklist_EUPAS20720

Signed checklist for study protocols

2017-0046_Checklist for Study Protocols_EUPAS20720

Data sources

• Data source(s):
  Danish registries (access/analysis)

  PHARMO Data Network

  German Pharmacoepidemiological Research Database
• Data sources (types):
  Administrative data (e.g. claims)

  Disease registry

  Drug dispensing/prescription data

  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