1. Running OpenCDISC in SAS
Kevin Lee

2. Disclaimer
Any views or opinions presented in this
presentation are solely those of the author
and do not necessarily represent those of the
company.
11/26/2013
Cytel Inc.
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3. Agenda
1. Introduction of OpenCDISC Validator
2. The Current Process of CDISC Compliance
Check
3. The New Process of CDISC Compliance Check
4. How to run OpenCDISC validator in SAS
5. Conclusion & Questions
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Cytel Inc.
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4. Introduction of OpenCDISC Validator
• a CDISC Compliance Check Software
• An Open‐Source Software
• The most recent version – 1.4, released in
March 14th, 2013
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Cytel Inc.
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5. Functionality of OpenCDISC Validator
• CDISC compliance validation
• SDTM
• ADaM
• Send
• Define.xml
• Creation of Define.xml
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Cytel Inc.
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6. OpenCDISC Validator Batch File
START /B javaw ‐Xms256m ‐Xmx1024m ‐jar lib/validator‐
gui‐1.3.jar
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7. Validator-gui-1.3.jar
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8. OpenCDISC Validator Interface
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9. OpenCDISC Validator Report
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10. Current Process of CDISC Compliance
Checks using OpenCDISC
SDTM DM
SAS
Program
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OpenCDISC
Validator
dm.xpt
Cytel Inc.
CDISC
Compliant
dm.xpt
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11. New Process of CDISC Compliance
Checks
SDTM DM SAS
Program with
OpenCDISC
Validator
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CDISC
Compliant
dm.xpt
Cytel Inc.
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12. OpenCDISC Validator Program Interface
gui
cli
api
core
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Cytel Inc.
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13. Call gui in SAS
****opening OpenCDISC Validator Interface;
x java ‐jar
"C:zotherindustryCDISCopencdiecopencdi
sc‐validator 1.3libvalidator‐gui‐1.3.jar";
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Cytel Inc.
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14. Use cli(Command Line Interpreter) (1)
C:zotherindustryCDISCopencdiscopencdisc‐
validator 1.3lib>java –jar validator‐cli‐1.3.jar –help
General Parameters
‐task Validate|Generate (Validate)
‐type SDTM|Define|Custom (SDTM)
Source Data Parameters
‐source <path>
‐source:type
SAS|Delimited (SAS)
‐source:delimiter <delimiter> (,)
‐source:qualifier <qualifier> (“)
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Cytel Inc.
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15. Use cli(Command Line Interpreter) (1)
C:zotherindustryCDISCopencdiscopencdisc‐
validator 1.3lib>java –jar validator‐cli‐1.3.jar –help
General Parameters
‐task Validate|Generate (Validate)
‐type SDTM|Define|Custom (SDTM)
Source Data Parameters
‐source <path>
‐source:type
SAS|Delimited (SAS)
‐source:delimiter <delimiter> (,)
‐source:qualifier <qualifier> (“)
11/26/2013
Cytel Inc.
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16. Use cli(Command Line Interpreter) (1)
C:zotherindustryCDISCopencdiscopencdisc‐
validator 1.3lib>java –jar validator‐cli‐1.3.jar –help
General Parameters
‐task Validate|Generate (Validate)
‐type SDTM|Define|Custom (SDTM)
Source Data Parameters
‐source <path>
‐source:type
SAS|Delimited (SAS)
‐source:delimiter <delimiter> (,)
‐source:qualifier <qualifier> (“)
11/26/2013
Cytel Inc.
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17. Use cli(Command Line Interpreter) (1)
C:zotherindustryCDISCopencdiscopencdisc‐
validator 1.3lib>java –jar validator‐cli‐1.3.jar –help
General Parameters
‐task Validate|Generate (Validate)
‐type SDTM|Define|Custom (SDTM)
Source Data Parameters
‐source <path>
‐source:type
SAS|Delimited (SAS)
‐source:delimiter <delimiter> (,)
‐source:qualifier <qualifier> (“)
11/26/2013
Cytel Inc.
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18. Use cli(Command Line Interpreter) (1)
C:zotherindustryCDISCopencdiscopencdisc‐
validator 1.3lib>java –jar validator‐cli‐1.3.jar –help
General Parameters
‐task Validate|Generate (Validate)
‐type SDTM|Define|Custom (SDTM)
Source Data Parameters
‐source <path>
‐source:type
SAS|Delimited (SAS)
‐source:delimiter <delimiter> (,)
‐source:qualifier <qualifier> (“)
11/26/2013
Cytel Inc.
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19. Use cli(Command Line Interpreter) (3)
• pass parameters to core(main java program)
• Type of works – Compliance check on data or
generation of Define.xml
• Location and format of source data
• Location of configuration file
• Location of Define.xml
• Report format
• Name and location of OpenCDISC Validator Report
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Cytel Inc.
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20. Running OpenCDISC Validator 1.3
x java
‐jar “C:zotherindustryCDISCopencdiecopencdisc‐
validator 1.3libvalidator‐cli‐1.3.jar"
‐task="validate"
‐type="sdtm"
‐source:type="sas"
‐source="C:datasdtmdm.xpt"
‐config="C:zotherindustryCDISCopencdiecopencdisc‐
validator 1.3configconfig‐sdtm‐3.1.2.xml"
‐report="C:dataopenCDISC_v1.3_DM.xls"
‐report:type="excel"
–report:overwrite=”yes”;
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Cytel Inc.
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21. Running OpenCDISC Validator 1.3
x java
‐jar “C:zotherindustryCDISCopencdiecopencdisc‐
validator 1.3libvalidator‐cli‐1.3.jar"
‐task="validate"
‐type="sdtm"
‐source:type="sas"
‐source="C:datasdtmdm.xpt"
‐config="C:zotherindustryCDISCopencdiecopencdisc‐
validator 1.3configconfig‐sdtm‐3.1.2.xml"
‐report="C:dataopenCDISC_v1.3_DM.xls"
‐report:type="excel"
–report:overwrite=”yes”;
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Cytel Inc.
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22. Running OpenCDISC Validator 1.4
x java
‐jar “C:zotherindustryCDISCopencdiscopencdisc‐validator
1.4libvalidator‐cli‐1.4.jar"
‐task="validate"
‐type="sdtm"
‐source:type="sas"
‐source="C:datasdtmdm.xpt"
‐config="C:zotherindustryCDISCopencdiecopencdisc‐validator
1.4configconfig‐sdtm‐3.1.3.xml"
–config:cdisc=”2012‐12‐21”
‐report="C:dataopenCDISC_v1.4_DM.xls"
‐report:type="excel"
–report:overwrite=”yes”;
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Cytel Inc.
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23. Conclusion
• Yes, we can run OpenCDISC validator in SAS
• One Process ‐ both creation of CDISC datasets
and compliance checks in a single process(SAS
program)
• A control on the location of the OpenCDISC
Validator Report.
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