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--- documentation:next_cdm:clinical_trial [2017/01/13 17:59]
vojtechhuser
+++ documentation:next_cdm:clinical_trial [2017/01/13 18:07] (current)
vojtechhuser
@@ Line 3: / Line 3: @@
 ===== Understanding Role / Relevance of Clinical Trial Data in the CDM=====
-Proposing person: Vojtech Huser (and possibly others)
+Proposing person: Vojtech Huser (someone initially posted this to the wiki (not indicating the source), I got assigned to it)
+Forum thread: http://forums.ohdsi.org/t/omop-cdm-and-clinical-trials/2109
+**Use Case(s):**
+. observational trial collects CRF data but also wants to digest any EHR updates (e.g., AllOfUs project)
+. multi site observational trial decides to use OMOP CDM as the schema for their pooled data
+. sponsor must provide trial data to FDA in SDTM format  (and has those currently in OMOP CDM)
+**Possible problems:**
+. convention for: person_id is in trial identified by NCT0000123456 and consented on date X
+. convention for: CRF data is mapped to concepts. And concepts dictate where it goes. E.g., hematocrit CRF question goes into MEASUREMENT; others go into OBSERVATION.
+. if CRF question does not map to any concept, what do we do?
+. convert OMOP CDM <Dx data> into SDTM
+. convert OMOP CDM <any data> into SDTM
-Forum thread:http://forums.ohdsi.org/t/omop-cdm-and-clinical-trials/2109

Observational Health Data Sciences and Informatics