Create additional SAS
data sets that contain metadata attributes for the optional BASICDEFINITIONS,
PRESENTATION, USER, LOCATION, and SIGNATURE statements. The LIBNAME
statement assigns the libref CURRENT to the physical location of the
SAS data sets that will store the metadata attributes.
libname current 'C:\mydata\';
data current.basic;
length TranslatedText $40.;
MeasurementOID="MU.KG";
Name="Kilogram";
Lang="en";
TranslatedText="English: Kilogram";
output;
MeasurementOID="MU.KG";
Name="Kilogram";
Lang="sp";
TranslatedText="Spanish: Kilogram";
output;
MeasurementOID="MU.LB";
Name="Pound";
Lang="en";
TranslatedText="English: Pound";
output;
MeasurementOID="MU.LB";
Name="Pound";
Lang="sp";
TranslatedText="Spanish: Libra";
output;
run;
data current.present;
length TranslatedText $40.;
PresentationOID="PRES.EN";
Lang="en";
TranslatedText="English: Presentation";
output;
PresentationOID="PRES.SP";
Lang="sp";
TranslatedText="Spanish: Presentation";
output;
run;
data current.location;
LocationOID="LOC.CDISCHome";
Name="CDISC Headquarters";
Studyoid="123-456-789";
MetadataversionOID="v1.1.0";
EffectiveDate="2001-10-19";
LocationType="Other";
output;
LocationOID="LOC.site001";
Name="Roswell Park";
StudyOID="123-456-789";
MetadataversionOID="v1.1.0";
EffectiveDate="2001-10-19";
LocationType="Site";
output;
run;
data current.user;
length usertype $20.;
length organization $40.;
UserOID="USR.cdisc001";
UserType="Other";
FullName="Fred Flintstone";
FirstName="Fred";
LastName="Flintstone";
Organization = "CDISC";
LocationOID="LOC.CDISCHome";
StreetName="123 Main Street";
City="Washington";
StateProv="DC";
Country="United States";
PostalCode="";
output;
UserOID="USR.inv001";
UserType="Investigator";
FullName="Wilma Flintstone";
FirstName="Wilma";
LastName="Flintstone";
Organization="Roswell Park";
LocationOID="LOC.site001";
StreetName="";
City="";
StateProv="";
Country="";
PostalCode="";
output;
run;
data current.signature;
SignatureOID="SD.cdisc001-es";
Methodology="Electronic";
Meaning="Signature Meaning";
LegalReason="LegalReason";
run;
Reference the SAS data
sets in a PROC CDISC program:
-
The FILENAME statement
assigns the fileref XMLOUT to the physical location of the output
XML document.
-
The required PROC CDISC
statement specifies CDISC ODM as the model and the fileref XMLOUT,
which references the physical location of the output XML document.
-
The required ODM statement
includes the DATA= argument to reference the SAS data set CURRENT.ODM,
which stores the CDISC ODM version and file type.
-
The required STUDY statement
includes the DATA= argument to reference the SAS data set CURRENT.STUDY,
which stores the study identifier.
-
The required GLOBALVARIABLES
statement includes the DATA= argument to reference the SAS data set
CURRENT.GLOBALS, which stores general summary information about the
study.
-
The optional BASICDEFINITIONS
statement includes the DATA= argument to reference the SAS data set
CURRENT.BASIC, which stores information about measurement units that
are used in the study.
-
The required METADATAVERSION
statement includes the DATA= argument to reference the SAS data set
CURRENT.METADATA, which stores the metadata version and version name.
-
The optional PRESENTATION
statement includes the DATA= argument to reference the SAS data set
CURRENT.PRESENT, which stores information about how the study is presented
to users.
-
The optional USER statement
includes the DATA= argument to reference the SAS data set CURRENT.USER,
which stores information about users involved in the study.
-
The optional LOCATION
statement includes the DATA= argument to reference the SAS data set
CURRENT.LOCATION, which stores information about the physical location
of the study.
-
The optional SIGNATURE
statement includes the DATA= argument to reference the SAS data set
CURRENT.SIGNATURE, which stores information about the signatures required
in administering the study.
-
The required CLINICALDATA
statement identifies the input SAS data set, which is CURRENT.AE.
The input SAS data set contains the data content and KeySet members
that are written to the XML document. In addition, the CLINICALDATA
statement specifies optional metadata attributes.
filename xmlout 'C:\XML\aeopts.xml'; 1
proc cdisc model=odm write=xmlout; 2
odm data=current.odm; 3
study data=current.study; 4
globalvariables data=current.globals; 5
basicdefinitions data=current.basic; 6
metadataversion data=current.metadata; 7
presentation data=current.present; 8
user data=current.user; 9
location data=current.location; 10
signature data=current.signature; 11
clinicaldata data=current.ae 12
domain="AE"
name = "Adverse Events"
comment = "Adverse Events in the Clinical Trial";
run;
filename xmlout clear;