CDISC ODM Procedure
CLINICALDATA Statement
When importing, identifies the output SAS data
set and specifies where the data content in the CDISC ODM XML document
begins; when exporting, identifies the input SAS data set and specifies
any optional metadata attributes.
Requirements: |
Required for both importing and exporting.
When exporting, the optional metadata attributes must
be specified in the CLINICALDATA statement.
|
Syntax
CLINICALDATA
OUT=libref.member-name SASDATASETNAME="name" |
DATA=libref.member-name <metadata-attributes> ;
Summary of Optional Arguments
Arguments
- OUT=libref.member-name
-
identifies the output
SAS data set. A SAS data set is any file that is accessed by SAS,
such as a SAS data file or a file that points to data from other sources,
such as a DBMS table that is accessed with a SAS/ACCESS engine. The libref, which is assigned with the LIBNAME statement,
is an alias for the data storage location where member-name is stored.
Requirement:Required for importing.
- SASDATASETNAME="name"
-
specifies a CDISC ODM
ItemGroupDef attribute that identifies where the data content in the
XML document begins. Enclose the name in single or double quotation
marks.
Requirement:Required for importing.
- DATA=libref.member-name
-
specifies the input
SAS data set that contains the clinical data and the required KeySet
members to be exported to the XML document. A SAS data set is any
file that is accessed by SAS, such as a SAS data file or a file that
points to data from other sources, such as a DBMS table that is accessed
with a SAS/ACCESS engine. The libref, which is assigned with the LIBNAME statement, is an alias for the
data storage location where member-name is stored.
The required KeySet
members include the following:
Requirement:Required for exporting.
- metadata-attributes
-
includes the following
syntax, which must be specified in the CLINICALDATA statement:
- NAME="string"
-
specifies the study
name. Enclose the string in single or double quotation marks.
Requirement:Optional for exporting.
- DOMAIN="domain-name
- ORIGIN="string"
- PURPOSE="string"
- COMMENT="string"
-
specifies submission
information as defined in CDISC Submission Metadata Model. Enclose
each value in single or double quotation marks.
Requirement:Optional for exporting.
- INVESTIGATORREF=NO | YES
-
determines whether
PROC CDISC imports the unique identifier for the investigator user.
INVESTIGATORREF=YES creates the SAS variable __USEROID in the imported
SAS data set.
Default:NO
Requirements:Optional for importing.
To specify INVESTIGATORREF=YES, you must also specify
ODMMINIMUMKEYSET=NO in the ODM statement.
- SITEREF=NO | YES
-
determines whether
PROC CDISC imports the unique identifier for the study location. SITEREF=YES
creates the SAS variable __LOCATIONOID in the imported SAS data set.
Default:NO
Requirements:Optional for importing.
To specify SITEREF=YES, you must also specify ODMMINIMUMKEYSET=NO
in the ODM statement.
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