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> ;

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.
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.