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.
Example:
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
Blask
Blue
Green
, Black, Blue, Green, Other,
specify
Specify:
SCTEST
= Eye Color
SCORRES
= BLUEISH GRAY
SCSTRESC
= OTHER
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:
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.