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 a Standard Field standard field is Represented 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 a Standard Field standard field is a Result Represented 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 pre-specified 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
To
maintain
If the sponsor wishes to maintain controlled terminology in the standard result field, but will
expand
the
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
"Specify" Values for Topic Variables
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
Interventions
If a list of specific treatments is provided along with "Other, Specify", --TRT should be populated with the name of the treatment found in the specified text. If the sponsor wishes to distinguish between the prespecified list of treatments and those recorded in "Other, Specify," the --PRESP variable could be used. For example:
Indicate which of the following concomitant medications was used to treat the subject’s headaches:
If ibuprofen and diclofenac were reported, the CM dataset would include the following:
CMTRT
CMPRESP
IBUPROFEN
Y
DICLOFENAC
Events
"Other, Specify" for events may be handled similarly to Interventions. --TERM should be populated with the description of the event found in the specified text and --PRESP could be used to distinguish between prespecified and free-text responses.
Findings
"Other, Specify" for tests may be handled similarly to Interventions.
--TESTCD and --TEST
should be populated with the code and description of the test found in the specified text. If specific tests are not listed on the CRF and the investigator has the option of writing in tests, then the name of the test would have to be coded to ensure that all --TESTCD and --TEST values are consistent with the test controlled terminology. For example, a lab CRF collected values for hemoglobin, hematocrit, and "Other, specify". The value the investigator wrote for "Other, specify" was "Prothrombin time" with an associated result and units. The sponsor would submit the controlled terminology for this test: LBTESTCD would be "PT" and LBTEST would be "Prothrombin Time", rather than the verbatim term, "Prothrombin time" supplied by the investigator.
in its own record per controlled terminology.
4
Data from a standard field is represented in variable --OBJ
When
"Specify" Values --OBJ
As illustrated in the following figure, when
findings are collected about an intervention or event
or intervention
, 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.
