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documentation:next_cdm:clinical_trial

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documentation:next_cdm:clinical_trial [2017/01/13 18:05]
vojtechhuser
documentation:next_cdm:clinical_trial [2017/01/13 18:05]
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 currently in OMOP CDM)  3. sponsor must provide trial data to FDA in SDTM format ​ (and has those currently in OMOP CDM)
documentation/next_cdm/clinical_trial.txt ยท Last modified: 2017/01/13 18:07 by vojtechhuser