Convention for representiong assignment of person to a clinical trial

[vojtechhuser]

Type	Notes
Item	Trial Enrollment information in OBSERVATION table
Forum Post	http://forums.ohdsi.org/t/omop-cdm-and-clinical-trials/2109

SOLUTION To represent clinical study/trial data in CDM use the following specifications (OBSERVATION table).

• For study/trial registed in ClinicalTrials.gov, use NCT id to refer to the study/trial. If NCT is not available, use other suitable trial identifier.

• Use the following concepts to represent trial/study events.

  • entering a trial - Enrollement (start)
    Observation_concept_id: http://www.ohdsi.org/web/atlas/#/concept/41637337 (Patient consented to clinical trial)
    value_as_string: NCT000035135
    
    
  • leaving the trial early (due to a decision of a patient (no longer interested) or researcher (non compliance) (end)
    Observation_concept_id:http://www.ohdsi.org/web/atlas/#/concept/40879071 (Patient withdrawn from trial)
    value_as_string: NCT000035135
    
    
  • fully completing the trial (end)
    Observation_concept_id: http://www.ohdsi.org/web/atlas/#/concept/404828402 Completion of clinical trial
    value_as_string: NCT000035135
    
    see details here
    https://github.com/OHDSI/CommonDataModel/issues/170

• each person ever entering a given trial/study, must have an end event (leaving early/fully completing) (heel notification; applied to trials identified by NCT whose primary completion date is prior end-of-data date. (METADATA table needs end-of-data entry)

NEXT STEPS: implement conventions outlined above

[vojtechhuser]

discussed today at WG-1.

3 codes that were proposed in 2017 were not objected to.

trials WG is not taking off that much so using THEMIS mechanism (and WG-x crowd) is best - gets larger quorum.

[vojtechhuser]

first post modified to have clear conventions

[cgreich]

@vojtechhuser: This is patient enrolled in a trial. How about declaring the collected data (CRF)? Is that also somewhere?

[vojtechhuser]

That is a good suggestion for the next convention.

Also, the status should say ratified since it was discussed in February Themis workgroup call and was advanced in status

[croeder]

@vojtechhuser I see where an observation gives us a place to store the trial identifier, does that have to do with why this isn't an observation_period entry?

[chrisroederucdenver]

@vojtechhuser I see where an observation gives us a place to store the trial identifier, does that have to do with why this isn't an observation_period entry?

Posted here from my Uni account instead of personal.

[MelaniePhilofsky]

@vojtechhuser Do you want to sponsor this issue? Or close this issue?