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The Supplemental Qualifiers (SUPP–) special purpose dataset model is used to represent nonstandard describe both:

  • Nonstandard variables (NSVs) which cannot be represented using standard variables from the domain or the SDTM
  • Attributions 

SUPP-- datasets are also used to capture attributions. An attribution is typically an interpretation or subjective classification of 1 or more observations by a specific evaluator (e.g., a diagnosis provided by a pathologist or veterinarian). It is possible that different attributions may be necessary in some cases; SUPP-- provides a mechanism for incorporating as many attributions as are necessary. A SUPP-- dataset can contain both objective data (where values are collected or derived algorithmically) and subjective data (attributions where values are assigned by a person or committee). For objective data, the value in QEVAL will be null. For subjective data, the value in QEVAL should reflect the role of the person assigning the value (e.g., "PATHOLOGIST", "VETERINARIAN").





The Related Records (RELREC) special-purpose dataset is used to describe relationships between records for a subject and relationships between datasets. 

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