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.
Metadataspec
Num
Variable Population
Implementation
1
When Data from Standard Field is Represented a standard field is represented in a Variable variable with Rolerole:
Grouping Qualifier,qualifier
Synonym Qualifier,qualifier
Record Qualifier; orqualifier
Variable Qualifierqualifier
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
a standard field is a result represented in --ORRES
When free
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 specified
prespecified 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:
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.
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.
CRF
Representation
Eye Color:
Brown, Black, Blue, Green, Other, Specify:
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
To expand terminology based on values
seen in the
collected from "Other, specify"
field
,
then the free text is placed
free text will be represented in --ORRESand the value of --STRESC will reflect the
sponsor
applicant's coding decision.
CRF
Representation
Eye Color:
Brown, Black, Blue, Green, Other, Specify:
SCTEST
SCORRES
SCSTRESC
Eye Color
BLUEISH GRAY
GRAY
If the
sponsor
applicant does not require that controlled terminology
be
is maintained, then the verbatim value will also be
copied to
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.
