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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 role of the variable used to represent data from the standard field.


  • Grouping Qualifier for variables which are used to group together a collection of observations within the same domain.
  • Result Qualifier for variables which describe the specific results associated with the topic variable in a Findings dataset.
  • Synonym Qualifier for variables which specify an alternative name for a particular variable in an observation.
  • Record Qualifier for variables which define additional attributes of the observation record as a whole, rather than describing a particular variable within a record
  • Variable qualifiers for variables which are used to further modify or describe a specific variable within an observation and are only meaningful in the context of the variable they qualify. 


NumVariable PopulationImplementation
1

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

  • Result Qualifier

When free-text is collected to supplement a standard Result Qualifier field, the free-text value will be represented dependent on the based on the applicant's coding practice and analysis requirements.

  • If the applicant wishes to maintain controlled terminology in the standard field and limit terminology to choices specified on the CRF, then collected free-text will be represented in --ORRES and controlled terminology will be represented in --STRESC.

For example, consider a CRF where the sponsor requests the subject's eye color:

Eye Color


  •   


An investigator has selected "OTHER" and specified "BLUEISH GRAY". As in the preceding discussion for non-result qualifier values, the sponsor has several options for submission:

  1. If the sponsor wishes to maintain controlled terminology in the standard result field and limit the terminology to the 5 prespecified choices, then the free text is placed in --ORRES and the controlled terminology in --STRESC.

    SCTEST

    SCORRES

    SCSTRESC

    Eye ColorBLUEISH GRAYOTHER

  2. If the sponsor wishes to maintain controlled terminology in the standard result field, but will expand the terminology based on values seen in the "Other, specify" field, then the free text is placed in --ORRES and the value of --STRESC will reflect the sponsor's coding decision.

    SCTEST

    SCORRES

    SCSTRESC

    Eye ColorBLUEISH GRAYGRAY

  3. If the sponsor does not require that controlled terminology be maintained, the verbatim value will be copied to --STRESC.

    SCTEST

    SCORRES

    SCSTRESC

    Eye ColorBLUEISH GRAYBLUEISH GRAY



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