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Generate CDISC Supplemental
Qualifiers non standard variables and their association to parent domain
%suppqual (data = source dataset,
varname = variable names,
rdomain = related domain,
studyid
= study identifer,
idvar
= identification variable,
usubjid
= unique subject id,
qorig
= variable names,
output = output dataset,
merge =
merge into one,
basecode = SAS/Base Code);
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Where
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Is Type...
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And represents...
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|
data |
C
(200) |
A two
level dataset name specification in the form of libname.dataname.
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|
varname |
C
(200) |
Relating record variables separated
by spaces. |
|
rdomain |
C
(200 optional) |
Related domain abbreviation to the
current dataset |
|
studyid |
C
(200) |
Study identifier. This can be
specified as a name or a numeric number. |
|
idvar |
C
(200 optional) |
Identification variable that
identifies the related records |
|
usubjid |
C
(200) |
Unique Subject Identifier of the SDS
domain record(s). |
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qorig |
C
(200 Optional) |
Original source of the variable.
Possible values include:
There must be a one to one
correspondence between the origin specifications relating to each
variable name. If this is left blank, it will default to CRF. |
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output |
C
(200 Optional) |
Output dataset name. This can
be either a two level or one level name. If it is one level, it
will be defaulted to be produced in the same location as specified in
the data parameter. If no value is specified, it will generate a
data set name SUPPQUAL in the default location. |
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merge |
C
(200 Optional) |
This will merge all the individual
SUPPQUAL by their relational domain into one large SUPPQUAL dataset.
Valid values include:
If yes is specified, an
additional program named suppqual_joiner.sas will be created to perform
the merging of the data.
NOTE: suppqual normally creates
datasets named SUPPQUAL_RDOMAIN where the "RDOMAIN" is the name
of the related domain dataset.
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basecode |
C
(200 optional) |
Saved location of SAS Base code
that is used to create the relational records dataset. |
Details
Because the SDTM does not allow for additional variables, the extra
metadata and data are stored in a separate SUPPQUAL dataset. One
common case for using SUPPQUAL is to capture attributions. An attribution
is typically an interpretation or subjective classification of one or more
observations by a specific evaluator, such as a population flag that
classifies a subject. An optional grouping identifier variable --GRPID
can be used in SUPPQUAL to identify individual qualifier values (SUPPQUAL
records) related to multiple domain records that could be grouped.
The data structure is as follows:
| Variable |
Variable Label |
Type |
CDISC Notes |
| STUDYID |
Study Identifier |
Char |
Study Identifier of the Parent record(s). |
| RDOMAIN |
Related Domain Abbreviation |
Char |
Domain Abbreviation of the Parent record(s). Null for an attribution
(e.g., ITT) that may apply for all records in all domains for a
subject. |
| USUBJID |
Unique Subject Identifier |
Char |
Unique Subject Identifier of the Parent record(s).
|
| IDVAR |
Identifier Variable |
Char |
Identifier variable in the dataset that identifies the related record(s).
Examples: --SEQ, --GRPID. |
| IDVARVAL |
Identifier Variable Value
|
Char |
Value of identifier variable of the parent record(s).
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| QNAM |
Qualifier Variable Name |
Char |
The short name of the Qualifier variable. This
variable should contain a text value less than or equal to 8 characters
in length, so the value could be used as a column name in a domain view
with data from the parent domain(s). This will often be the column name
in the sponsor’s original dataset. QNAM values can only include
alphanumeric characters and the underscore (_) and cannot start with a
number. |
| QLABEL |
Qualifier Variable Label |
Char |
This is the long name or label associated with QNAM.
This should be less than or equal to 40 characters. This will often be
the column label in the sponsor’s original dataset.
|
| QVAL |
Data Value |
Char |
Result of, response to, or value associated with
QNAM. A value for this column is required; no records can be in SUPPQUAL
with a Null value for QVAL. |
| QORIG |
Origin |
Char |
Since QVAL can represent a mixture of collected (on
a CRF), derived, or assigned items, QORIG is used to indicate the origin
of this data. Controlled terminology: CRF, ASSIGNED, or DERIVED.
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| QEVAL |
Evaluator |
Char |
Used only for results that are subjective (e.g.,
assigned by a person or a group). Should be Null for records that
contain objectively collected or derived data. Controlled terminology
will consist of values such as ADJUDICATION COMMITTEE, STATISTICIAN,
DATABASE ADMINISTRATOR, CLINICAL COORDINATOR, PRIMARY INVESTIGATOR, etc.
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Each time the %suppqual is called,
it will append the specified variables into the suppqual dataset. If
the variable already exists, it will update the information.
The basecode parameter will generate
SAS/BASE code that will perform the same task of transposing input data into
the SUPPQUAL dataset. In addition, it will generate optional code that
can be used to perform the reverse transposition from SUPPQUAL back into the
original data structure. This is useful if you have legacy code that
you wish to use with the SUPPQUAL data. This reverse
transposition code can be regenerate the data that can then be used with the
original legacy code.
Example
%suppqual (data=mylib.ae,
varname=cmgrpid cmtrt cmdecod cmdose cmdosu cmstdtc cmendtc,
rdomain=AE);
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