What are the Common Issues in Mapping Dummy corporate standards to CDISC (SDTM) Standards?
• 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. • Dictionary codes not in SDTM parent module, so if needed must be collected in SUPPQUAL. • Core SDTM is a subset of the existing corporate standards • Different structure of Lab CDISC Domain e.g. baseline flag. • Vertical versus Horizontal structure, (e.g. Vitals) • Additional Metadata needed to describe the source in SUPPQUAL • 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.
