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 accompanied by 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 tabulation variable used to represent data from the standard field. In this section, non-result qualifier refers.
- 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.
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| Num | Variable Population | Implementation |
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| 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 |
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| is collected to supplement a standard non-result qualifier field, the free-text value |
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| represented in the SUPP-- dataset |
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| . | | 2 | When Data from Standard Field is Represented in a Variable with Role | 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 |
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- AESMIE = "Y"
- SUPPAE QNAM = "AESOSP", QLABEL = "Other Medically Important SAE", QVAL = "HIGH RISK FOR ADDITIONAL THROMBOSIS"
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Another example is a CRF that collects reason for dose adjustment with additional free-text description:
The free-text description should be stored in the SUPPEX dataset.
- EXADJ = "NONMEDICAL REASON"
SUPPEX QNAM = "EXADJDSC", QLABEL = "Reason For Dose Adjustment Description", QVAL = "PATIENT MISUNDERSTOOD INSTRUCTIONS"
Note that QNAM references the "parent" variable name with the addition of "DSC". Likewise, the label is a modification of the parent variable label.
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'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 |
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where the sponsor requests the subject's eye color: |
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An investigator has selected "OTHER" and specified " |
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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
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standard result field and limit the terminology to the 5 prespecified choices, then the free text is placed
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in --ORRES and the controlled terminology in --STRESC.
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QVAL
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If the sponsor wishes to maintain controlled terminology
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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
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--STRESC will reflect the sponsor's coding decision
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Note that the sponsor might choose a different value for CMINDC (e.g., "BONE FRACTURE") depending on the sponsor's coding practice and analysis requirements.
If the sponsor does not require that controlled terminology be maintained
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, the verbatim value will be copied to --STRESC. SCTEST | SCORRES | SCSTRESC |
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| Eye Color | BLUEISH GRAY | BLUEISH GRAY |
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CMINDC
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