New working group: Clinical Trials

Brief overview of proposals from our presentation today:

  • Trial visit (Vocabulary extension)
    Add visit concepts specific for trials, like Baseline, Screening, Follow-up, Cycle #
  • Study (CDM extension)
    Table with study and arm metadata and assignment of persons to a study/arm.
  • Measurement modifiers (CDM extension)
    Table like the fact_relationship table that connects a fact (e.g. condition_occurrence_id) to a concept_id. This allows for a flexible way of connecting more attributes to a record. This proposal is based on the modifier domain in the tranSMART data model
1 Like