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.
| Metadataspec |
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| Num | Variable Population | Implementation |
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| 1 | Data from a standard field is represented in a variable with role: - Grouping qualifier
- Synonym qualifier
- Record qualifier
- 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 | 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 prespecified 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.
| CRF | Representation |
|---|
Eye Color: Brown, Black, Blue, Green, Other, Specify: | SCTEST | SCORRES | SCSTRESC | Eye Color | BLUEISH GRAY | OTHER |
| CRF | Representation |
|---|
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..
| CRF | Representation |
|---|
Eye Color: Brown, Black, Blue, Green, Other, Specify: | SCTEST | SCORRES | SCSTRESC | Eye Color | BLUEISH GRAY | BLUEISH GRAY |
| | 3 | Data from a standard field is represented in a topic variable | - For Interventions general-observation class domains, each collected value will be represented in --TRT in its own record.
- For Events general-observation class domains, each collected value will be represented in --TERM in its own record.
- For Findings general-observation class domains, each collected value will be represented in --TESTCD and --TEST in its own record per controlled terminology.
| | 4 | 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.  Image Added
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