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--- documentation:next_cdm:clinical_trial [2015/12/21 03:40]
jduke created
+++ documentation:next_cdm:clinical_trial [2017/01/13 18:05]
vojtechhuser
@@ Line 1: / Line 1: @@
 ===== Understanding Role / Relevance of Clinical Trial Data in the CDM=====
+Proposing person: Vojtech Huser (and possibly others)
+Forum thread:http://forums.ohdsi.org/t/omop-cdm-and-clinical-trials/2109
+**Use Case:**
+. 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 XYZ
+. convention for: CRF data is mapped to concepts. And concepts dictate where it goes. E.g., hematocrit question goes into MEASUREMENT others go into observation
+. convert OMOP CDM <Dx data> into SDTM
+. convert OMOP CDM <any data> into SDTM
+===== Archived content =====
 Many organizations using the OMOP CDM for observational data are also charged with the production and handling of clinical trials data.  One common format (that required for FDA submission) is the [[http://www.cdisc.org/system/files/all/standard_category/application/pdf/study_data_tabulation_model_v1_4.pdf|CDISC Study Data Tabulation Model]].

Observational Health Data Sciences and Informatics