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Metadataspec
NumVariable PopulationImplementation
1

When Data from a Standard Field is Represented in a Variable with Role:

  • Grouping Qualifier,
  • Synonym Qualifier,
  • Record Qualifier; or
  • Variable Qualifier
When free text is collected to supplement a standard non-result qualifier field, the free text value will be represented in the SUPP-- dataset.
2

When Data from a Standard Field is a Result Represented in --ORRES.

When free text is collected to supplement a result, representation of the value will depend on the applicant's coding practice and analysis requirements.

  • To maintain controlled terminology pre-specified on the CRF, free text will be represented in --ORRES and controlled terminology will be represented in --STRESC. For example, if eye color is collected as a subject characteristic and "blueish gray" is collected for Other, specify, then free text may be represented in SCORRES and controlled terminology may be represented in SCSTRESC. 
CRFRepresentation

Eye Color:

Brown, Black, Blue, Green, Other, Specify:

SCTEST

SCORRES

SCSTRESC

Eye Color

BLUEISH GRAY

OTHER

  • To expand terminology based on values collected from "Other, specify", free text will be represented in --ORRES and the value of --STRESC will reflect the applicant's coding decision.

CRFRepresentation

Eye Color:

Brown, Black, Blue, Green, Other, Specify:

SCTEST

SCORRES

SCSTRESC

Eye Color

BLUEISH GRAY

GRAY

  • If the applicant does not require that controlled terminology is maintained, then the verbatim value will also be represented in --STRESC..
CRFRepresentation

Eye Color:

Brown, Black, Blue, Green, Other, Specify:

SCTEST

SCORRES

SCSTRESC

Eye Color

BLUEISH GRAY

BLUEISH GRAY

3When Data from a Standard Field is Represented in a Topic Variable
  • For Interventions general observations class domains, each collected value will be represented in --TRT in its own record. 
  • For Events general observations class domains, each collected value will be represented in --TERM in its own record.
  • For Findings general observations class domains, each collected value will be represented in --TESTCD and --TEST in its own record per controlled terminology. 
4When Data from a Standard Field is Represented in Variable --OBJ

When findings are collected about an intervention or event, and the name of the event or intervention is collected in an "Other, specify" CRF field, the value in --OBJ variable depends on whether the Findings record has a parent record and whether the "Other, specify" value was coded.

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