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 scope or role of the tabulation variable used to represent data from the standard collection field.
Metadataspec
Num
Variable Population
Implementation
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
AESMIE = "Y"
SUPPAE QNAM = "AESOSP", QLABEL = "Other Medically Important SAE", QVAL = "HIGH RISK FOR ADDITIONAL THROMBOSIS"
...
Adverse Event
...
Insufficient Response
...
Non-medical Reason
...
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.
...
'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,
...
An investigator has selected "OTHER" and specified "Broken arm". Several options are available for submission of this data:
...
If the sponsor wishes to maintain controlled terminology for the CMINDC field and limit the terminology to the 5 prespecified choices, then the free text is placed in SUPPCM.
CMINDC
OTHER
QNAM
QLABEL
QVAL
CMINDOTH
Other Indication
BROKEN ARM
...
CMINDC
FRACTURE
QNAM
QLABEL
QVAL
CMINDOTH
Other Indication
BROKEN ARM
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
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.
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.
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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 and wishes for all responses to be stored in a single variable, then CMINDC will be used and SUPPCM is not required.
