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CDISC Procedure Examples for CDISC ODM

Example: Importing a CDISC ODM XML Document Using Default KeySet Processing


Overview

This example imports clinical trials data from a CDISC ODM XML document that is named AE.XML, and creates a SAS data set that is named RESULTS.AE.

The example illustrates the default behavior for KeySet members written to the output SAS data set. All KeySet members that are in the input XML document are converted to SAS variables and values in the output SAS data set.

To view the AE.XML document, see Sample CDISC ODM XML Document.


Program

The following SAS program imports the XML document as a SAS data set:

  1. The LIBNAME statement assigns the libref RESULTS to the physical location of the output SAS data set.

  2. The FILENAME statement assigns the fileref XMLINP to the physical location of the input XML document (complete pathname, filename, and file extension) to be imported.

  3. The PROC CDISC statement specifies the following:

    • CDISC ODM as the model.

    • Fileref XMLINP, which references the physical location of the input XML document to be imported.

    • FORMATACTIVE=YES to convert CDISC ODM CodeList content in the XML document to SAS formats.

    • FORMATNOREPLACE=NO to replace existing SAS formats in the FORMAT catalog that have the same name as the converted formats.

  4. ODMMINIMUMKEYSET=NO in the ODM statement specifies that all KeySet members are written to the output SAS data set. This is the default setting for ODMMINIMUMKEYSET=.

  5. The CLINICALDATA statement identifies the output SAS data set, which is RESULTS.AE, and specifies the CDISC ODM ItemGroupDef attribute that indicates where the data content in the XML document begins, which is AE.

  6. The CONTENTS procedure lists the contents of the output SAS data set. The VARNUM option lists the variables in the order in which they were created.

libname results 'C:\myfiles\'; 1 

filename  xmlinp  'C:\XML\ae.xml'; 2 

proc cdisc model=odm 3 
                  read=xmlinp 
                  formatactive=yes 
                  formatnoreplace=no;
   odm odmversion="1.2" odmminimumkeyset=no; 4  
   clinicaldata out=results.AE sasdatasetname="AE"; 5 
run;

proc contents data=results.AE varnum; 6  
run;

filename xmlinp clear;

libname results clear;


Output

The output from PROC CONTENTS displays the attributes of each interpreted variable, such as the variable's type and length. The attributes are obtained from the embedded metadata content.

Because ODMMINIMUMKEYSET=NO, all KeySet members are written to the output SAS data set. These are the first 10 variables listed in the output. (The first two characters in resulting SAS variable names are two underscores.)

The maximum OID length, which is 100, is allocated to each KeySet member.

PROC CONTENTS Output for RESULTS.AE

                                         The SAS System                                         1

                                     The CONTENTS Procedure

     Data Set Name        RESULTS.AE                             Observations          2
     Member Type          DATA                                   Variables             29
     Engine               V9                                     Indexes               0
     Created              Monday, March 09, 2009 10:25:34 AM     Observation Length    1208
     Last Modified        Monday, March 09, 2009 10:25:34 AM     Deleted Observations  0
     Protection                                                  Compressed            NO
     Data Set Type                                               Sorted                NO
     Label                Some adverse events from this trial
     Data Representation  WINDOWS_32
     Encoding             wlatin1  Western (Windows)


                               Engine/Host Dependent Information

                           Data Set Page Size          16384
                           Number of Data Set Pages    1
                           First Data Page             1
                           Max Obs per Page            13
                           Obs in First Data Page      2
                           Number of Data Set Repairs  0
                           Filename                    C:\ae.sas7bdat
                           Release Created             9.0202M0
                           Host Created                XP_PRO

                                         The SAS System           10:23 Monday, March 9, 2009   2

                                     The CONTENTS Procedure

                                   Variables in Creation Order

                #    Variable                 Type    Len    Format       Informat

                1    __StudyOID               Char    100
                2    __MetaDataVersionOID     Char    100
                3    __SubjectKey             Char    100
                4    __StudyEventOID          Char    100
                5    __StudyEventRepeatKey    Char    100
                6    __FormOID                Char    100
                7    __FormRepeatKey          Char    100
                8    __ItemGroupOID           Char    100
                9    __ItemGroupRepeatKey     Char    100
               10    __TransactionType        Char    100
               11    TAREA                    Char      4    $TAREAF.
               12    PNO                      Char     15
               13    SCTRY                    Char      4    $SCTRYF.
               14    F_STATUS                 Char      1    $F_STATU.
               15    LINE_NO                  Num       8                 2.
               16    AETERM                   Char    100
               17    AESTMON                  Num       8                 2.
               18    AESTDAY                  Num       8                 2.
               19    AESTYR                   Num       8                 4.
               20    AESTDT                   Num       8    DATE.
               21    AEENMON                  Num       8                 2.
               22    AEENDAY                  Num       8                 2.
               23    AEENYR                   Num       8                 4.
               24    AEENDT                   Num       8    DATE.
               25    AESEV                    Char      1    $AESEV.
               26    AEREL                    Char      1    $AEREL.
               27    AEOUT                    Char      1    $AEOUT.
               28    AEACTTRT                 Char      1    $AEACTTR.
               29    AECONTRT                 Char      1    $AECONTR. 

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