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documentation:next_cdm:clinical_trial [2017/01/13 18:04] vojtechhuser |
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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 in OMOP CDM) | + | 3. sponsor must provide trial data to FDA in SDTM format (and has those currently in OMOP CDM) |