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Answer» Here are some examples for SDTM mapping:
- CHARACTER variables defined as Numeric
- Numeric Variables defined as Character
- Variables collected WITHOUT an obvious corresponding DOMAIN in the CDISC SDTM mapping. So must go into SUPPQUAL
- Several corporate modules that map to one corresponding domain in CDISC SDTM.
- Core SDTM is a subset of the existing corporate standards
- Vertical versus Horizontal structure, (e.g. Vitals)
- Dates – combining date and times; partial dates.
- DATA collapsing issues e.g. Adverse Events and Concomitant Medications.
- Adverse Events maximum intensity
- Metadata needed to LABORATORY data standardization.
Here are some examples for SDTM mapping:
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