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.
Grouping Qualifierfor variables which are used to group together a collection of observations within the same domain.
Result Qualifierfor variables which describe the specific results associated with the topic variable in a Findings dataset.
Synonym Qualifierfor variables which specify an alternative name for a particular variable in an observation.
Record Qualifierfor variables which define additional attributes of the observation record as a whole, rather than describing a particular variable within a record
Variable qualifiersfor 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.
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Metadataspec
Num
Variable Population
Implementation
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 standard Result Qualifier field, the free-text value will be represented dependent on the based on the result, representation of the value will depend on the applicant's coding practice and analysis requirements.
If the applicant wishes to To maintain controlled terminology in the standard field and limit terminology to choices pre-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:
Example:
CRF
Representation
Eye Color:
Brown
Blask
Blue
Green
Other, specify:
SCTEST = Eye Color
SCORRES = BLUEISH GRAY
SCSTRESC = OTHER
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:
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 Color
BLUEISH GRAY
OTHER
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 Color
BLUEISH GRAY
GRAY
If the sponsor does not require that controlled terminology be maintained, the verbatim value will be copied to --STRESC.