I'm trying to implement clinical trials data into OMOP CDM format, particularly the trial design model data.
This includes: trial summary, inclusion/exclusion criteria for entering the trial, trial arms description,
trial elements for arms description etc.
1.Put trial summary as COHORT_DEFINITION.COHORT_DEFINITION_DESCRIPTION
(as most of such data is identical for all arms inside separate trial, description will be duplicated for each cohort)
2. Create set of inclusion/exclusion criteria as attribute in ATTRIBUTE_DEFINITION and bind each cohort with them in
It seems applicable, but I have some doubts about potential problem:due to OMOP CDM specification
attributes are derived elements, but such criteria are not necessary duplicated in trial data.
(for ex. if some disease occurrence is inclusion criterion, patient included in the trial has it by default -so such condition_occurrence is not necessary mentioned. In such case attribute exists as independent element,not derived from data)
Friends, will be glad to see you comments/advice on this topic