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For the TIG Product Impact on Individual Health use case, applicants may collect free text data on a CRF to supplement a standard field. A common example is collection using a list of choices with a field to collect "Other, specify". In such cases, collected free text will be populated in the domain based on the scope or role of the variable used to represent data from the standard collection field.


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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