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Comment: Assumption 1 language, replaced references to study drugs with "product"
  1. One way a sponsor may choose to differentiate different types of medicationsproducts, (e.g., study medication, rescue medication, run-in medicationproduct, comparator product) is to use DACAT.
  2. DAREFID and DASPID are both available for capturing label information.
  3. Any Identifiers, Timing variables, or Findings general observation class qualifiers may be added to the DA domain, but the following Qualifiers would not generally be used in DA: --MODIFY, --POS, --BODSYS, --ORNRLO, --ORNRHI, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --METHOD, --BLFL, --FAST, --DRVFL, --TOX, --TOXGR, --SEV.