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| Request | Notes | Status | Fixed/Updated/Removed from SDTMIG v4.0? | ||||||||||||||
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This is sponsor inquiry. How do you model pre-specified ANA tests? | Question about how to model ANA data that are collected, and therefore should be molded differently from the example that's shown in the SDTMIG 3.4. |
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Added to SDTMIG v4.0. |
User Inquiry:
"I wanted to revisit this discussion on ANA pattern reporting. We also deal with testing labs where they pre-coordinate the pattern result into the test name and perform a call of whether the pattern is observed or not. For example, the 'test' the lab performs evaluates each staining pattern as listed below:
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- Team is happy with both approaches, this "reciprocal" modeling approach provides flexibility and allows sponsors to accommodate different data collection schemas. It is also highly consistent with LOINC, both example have LOINC codes corroboration.
- Jordan to enter this into the CDISC Example Libraryalready added this one to the SDTMIG v4.0.
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