CDISC Procedure for CDISC ODM

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.

Requirement:	Required for both importing and exporting.
Requirement:	When exporting, the optional metadata attributes must be specified in the CLINICALDATA statement.

CLINICALDATA

OUT=libref.member-name SASDATASETNAME="name" |

DATA=libref.member-name <metadata-attributes> ;

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:

	__STUDYOID
	__METADATAVERSIONOID
	__SUBJECTKEY
	__STUDYEVENTOID
	__STUDYEVENTREPEATKEY
	__FORMOID
	__FORMREPEATKEY
	__ITEMGROUPOID
	__ITEMGROUPREPEATKEY
	__TRANSACTIONTYPE

Requirement:	Required for exporting.
See also:	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
Requirement:	Optional for importing.
Requirement:	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
Requirement:	Optional for importing.
Requirement:	To specify SITEREF=YES, you must also specify ODMMINIMUMKEYSET=NO in the ODM statement.

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