Long term, prospective, observational cohort study evaluating the safety profile in patients with highly active relapsing multiple sclerosis (RMS) newly started on oral cladribine − CLARION

ENCePP Code of conduct

Yes

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

Conflict(s) of interest of investigators

Composition of steering group and observers

MS700568-0002 CLARION protocol v1.9_Composition of Steering Committee and Observers

MS700568-0002 CLARION_Composition of Steering Committee_v4.0

Signed code of conduct

2018-0051_Declaraton compliance with Code

ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct__signed_IB_RK_16JUN2021

Signed code of conduct checklist

2018-0051_CoC checklist

ENCePPCoCAnnex2_ChecklistofCodeofConduct__signed IB 11JUN2021

Signed checklist for study protocols

2018-0051_Checklist for Study Protocol

CLARION_v4.0.Checklist for Study Protocol_Redacted

Data sources

• Data source(s), other:
  • Multiple sclerosis management system 3 Dimension, Germany; • Observatoire Français de la Sclérose en Plaques, France; • Italian multiple sclerosis and related disorders Registry; • MSBase: Australia, Belgium, Canada, Croatia, Kuwait, Lebanon, the Netherlands and Turkey; • The national healthcare and MS registers in Denmark, Finland, Norway, and Sweden; • The Swiss MS Cohort (Switzerland); • US DOD
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  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