1. Generating Define.xml at Kendle using DefinedocTM
Presentation at the CDISC German Speaking User Group Face To Face Meeting
Emöke Merli, 11Mar2010
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2. Outline Define.xml Generation Process Overview 4 Steps to Define.xml
DefinedocTM Software
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3. Define.xml Generation Process Overview
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4. Kendle SDTM Validation Checks
Based upon WebSDMTM edit checks as published on the CDISC website
Based upon Janus guideline 'SDTM Validation Specification' as published on the FDA homepage
Based upon OpenCDISC Rules
Additional SDTM validation checks implemented by Kendle

5. Define.xml Checks and QC
Kendle SAS® macros and programs for check of define.xml specific content (in addition to the Kendle SDTM Validation Checks)
Define.xml syntax validation against the CDISC schemas using Eclipse Xerces XML parser
Manual check of define.xml file (e.g. hyperlinking)

6. 4 Steps to Define.xml
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7. 4 Steps to Define.xml
Include all files in correct directory and run DefinedocTM to generate initial define.xml file
Run SAS® programs to include information from Excel® metadata specification document into SAS® working file and to perform checks
Run DefinedocTM for the second time to generate an updated define.xml file by including the metadata from the SAS® working files
Run SAS® programs to modify the layout of the define.xml and define.xsl files and to perform checks
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8. Final Define.xml Example
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9. DefinedocTM - Software
Product of MetaXceed Co. Ltd.
User interface based on SAS®
Automatically captures metadata available in SAS® datasets (XPT or SAS7BDAT)
Metadata not available in SAS® datasets is entered manually
Creates define.xml (also PDF, RTF and XLS)
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10. DefinedocTM – Data Definition Screen
Define project and study
Define input SAS® datasets (CDISC order)
Define source data path
Define output file (e.g. define.xml)
Define output library
Define order of variables (e.g. natural order)
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11. DefinedocTM – Data Definition Screen
Define project and study
Define input SAS® datasets (CDISC order)
Define source data path
Define output file (e.g. define.xml)
Define output library
Define order of variables (e.g. natural order)
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12. DefinedocTM – General Information Screen
Define text that will appear in define.xml title
Define relative link to XPT files
Define CRF location and name
Define layout
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13. DefinedocTM – Data Definition Screen
Define project and study
Define input SAS® datasets (CDISC order)
Define source data path
Define output file (e.g. define.xml)
Define output library
Define order of variables (e.g. natural order)
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14. DefinedocTM – Edit Definition Screen
Define dataset metadata
Define variable metadata
Click on ‘Value Level‘ button to define value-level metadata
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15. DefinedocTM – Edit Definition Screen
Define dataset metadata
Define variable metadata
Click on ‘Value Level‘ button to define value-level metadata
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16. DefinedocTM - Output
DefinedocTM generates the following files in defined output library
File
Description
define.xml
XML file
define.xsl
Stylesheet corresponding to XML file
_define.sas7bdat
DefinedocTM working file containing information (dataset and variable metadata) for define.xml generation
_define_bak.sas7bdat
Backup of _define.sas7bdat file
_definea.sas7bdat
Audit trail
_definea_bak.sas7bdat
Backup of _definea.sas7bdat file
_defineco.sas7bdat
DefinedocTM working file containing information (value-level metadata) for define.xml generation
icon1.gif, icon2.gif, icon3.gif
Pictures for navigation bar
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17. Questions? Contact Emöke Merli: merli.emoeke@kendle.com
Tel: +49 (0)
Reference
MetaXceed Home
“Creation of define.xml at Kendle using DefinedocTM: implementation, obstacles and enhancements“ Paper published in Pharmacoutical Programming Journal by Maney, Volume 2, Number 2, December 2009 , pp (11)
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18. Real people. Real results.®
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