A Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN) (TEG4001)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Other data source
• Data sources (types):
  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  For both cohorts, data will be extracted from the patient’s medical records by site personnel. Once written informed consent has been obtained, study site personnel will complete the baseline data collection for each patient. Follow-up data for patient visits will be recorded in the patient chart in accordance with the clinical site’s standard of care or clinical judgment. All data will be abstracted from medical records and entered into the EDC on an ongoing basis.

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