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Generating Define.xml at Kendle using Definedoc TM. Presentation at the CDISC German Speaking User Group Face To Face Meeting. Emöke Merli, 11Mar2010. Outline. Define.xml Generation Process Overview 4 Steps to Define.xml Definedoc TM Software. Define.xml Generation Process Overview.
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Generating Define.xml at Kendle using DefinedocTM Presentation at the CDISC German Speaking User Group Face To Face Meeting Emöke Merli, 11Mar2010
Outline • Define.xml Generation Process Overview • 4 Steps to Define.xml • DefinedocTM Software
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
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)
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
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)
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)
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)
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
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)
DefinedocTM – Edit Definition Screen • Define dataset metadata • Define variable metadata • Click on ‘Value Level‘ button to define value-level metadata
DefinedocTM – Edit Definition Screen • Define dataset metadata • Define variable metadata • Click on ‘Value Level‘ button to define value-level metadata
DefinedocTM - Output • DefinedocTM generates the following files in defined output library
Questions? • Contact • Emöke Merli: merli.emoeke@kendle.com Tel: +49 (0) 89 99 39 13 - 181 • Reference • MetaXceed Home http://www.meta-x.com/definedoc/index.html • “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. 65-75(11)