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documentation:next_cdm:clinical_trial [2017/01/13 18:05] vojtechhuser |
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===== Understanding Role / Relevance of Clinical Trial Data in the CDM===== | ===== 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 | + | Forum thread: http://forums.ohdsi.org/t/omop-cdm-and-clinical-trials/2109 |
- | **Use Case:** | + | |
+ | **Use Case(s):** | ||
1. observational trial collects CRF data but also wants to digest any EHR updates (e.g., AllOfUs project) | 1. observational trial collects CRF data but also wants to digest any EHR updates (e.g., AllOfUs project) | ||
- | 2. multi site trial decides to use OMOP CDM as the schema for their pooled data | + | 2. multi site observational trial decides to use OMOP CDM as the schema for their pooled data |
3. sponsor must provide trial data to FDA in SDTM format (and has those currently in OMOP CDM) | 3. sponsor must provide trial data to FDA in SDTM format (and has those currently in OMOP CDM) | ||
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**Possible problems:** | **Possible problems:** | ||
- | 1. convention for: person_id is in trial identified by NCT0000123456 and consented on date XYZ | + | 1. convention for: person_id is in trial identified by NCT0000123456 and consented on date X |
+ | |||
+ | 2. 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. | ||
- | 2. 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 | + | 3. if CRF question does not map to any concept, what do we do? |
3. convert OMOP CDM <Dx data> into SDTM | 3. convert OMOP CDM <Dx data> into SDTM |