documentation:next_cdm:clinical_trial
Differences
This shows you the differences between two versions of the page.
| Both sides previous revision Previous revision Next revision | Previous revision Last revision Both sides next revision | ||
|
documentation:next_cdm:clinical_trial [2017/01/13 17:59] vojtechhuser |
documentation:next_cdm:clinical_trial [2017/01/13 18:05] vojtechhuser |
||
|---|---|---|---|
| Line 6: | Line 6: | ||
| 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:** | ||
| + | 1. observational trial collects CRF data but also wants to digest any EHR updates (e.g., AllOfUs project) | ||
| + | |||
| + | 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) | ||
| + | |||
| + | |||
| + | **Possible problems:** | ||
| + | |||
| + | 1. convention for: person_id is in trial identified by NCT0000123456 and consented on date XYZ | ||
| + | |||
| + | 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. convert OMOP CDM <Dx data> into SDTM | ||
| + | |||
| + | 4. convert OMOP CDM <any data> into SDTM | ||
| + | |||
| + | |||
| + | |||
documentation/next_cdm/clinical_trial.txt ยท Last modified: 2017/01/13 18:07 by vojtechhuser
Page Tools
