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. | |
| Examples: | Importing a CDISC ODM XML Document Using Default KeySet Processing Importing a CDISC ODM XML Document Specifying KeySet Processing Options Importing a CDISC ODM XML Document Using a Language Identifier Importing a CDISC ODM XML Document with OrderNumber Attributes Exporting a CDISC ODM XML Document with Metadata Attributes in Statement Syntax Exporting a CDISC ODM XML Document with Metadata Attributes in SAS Data Sets Exporting a CDISC ODM XML Document with Required and Optional Statements |
Syntax
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.
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__STUDYOID
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__METADATAVERSIONOID
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__SUBJECTKEY
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__STUDYEVENTOID
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__STUDYEVENTREPEATKEY
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__FORMOID
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__FORMREPEATKEY
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__ITEMGROUPOID
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__ITEMGROUPREPEATKEY
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__TRANSACTIONTYPE
| Requirement | Required for exporting. |
| See | CDISC ODM KeySet Members |
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. |