Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea (REMSIMA_PMS)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  The sponsor, when visiting the study center, will collect Clinical Research Forms (CRFs) completed during the run-in period. Any and all documents created during the re-examination period including records about post-marketing surveillance, source documents and CRFs shall be placed on file immediately when collected and kept in proper storage for three years after completion of the re-examination.

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:
  Unknown