When Data from a Standard Field is Represented in a Variable with Role:
Grouping Qualifier,
Synonym Qualifier,
Record Qualifier; or
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
When 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 pre-specified 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
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:
To maintain
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.
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 terminology based on values seen in the "Other, specify" field, then the free text is placed in --ORRES and the value of --STRESC will reflect the sponsor's coding decision.
SCTEST
SCORRES
SCSTRESC
Eye Color
BLUEISH GRAY
GRAY
If the sponsor does not require that controlled terminology be maintained, the verbatim value will be copied to --STRESC.
SCTEST
SCORRES
SCSTRESC
Eye Color
BLUEISH GRAY
BLUEISH GRAY
"Specify" Values for Topic Variables
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.
"Specify" Values --OBJ
As illustrated in the following figure, when findings are collected about an 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. See also Section 6.4.3,Variables Unique to Findings About.
