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Generating Define.xml at Kendle using Definedoc TM

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 Definedoc TM

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  1. Generating Define.xml at Kendle using DefinedocTM Presentation at the CDISC German Speaking User Group Face To Face Meeting Emöke Merli, 11Mar2010

  2. Outline • Define.xml Generation Process Overview • 4 Steps to Define.xml • DefinedocTM Software

  3. Define.xml Generation Process Overview

  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

  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

  8. Final Define.xml Example

  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)

  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)

  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)

  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

  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)

  14. DefinedocTM – Edit Definition Screen • Define dataset metadata • Define variable metadata • Click on ‘Value Level‘ button to define value-level metadata

  15. DefinedocTM – Edit Definition Screen • Define dataset metadata • Define variable metadata • Click on ‘Value Level‘ button to define value-level metadata

  16. DefinedocTM - Output • DefinedocTM generates the following files in defined output library

  17. 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)

  18. Real people. Real results.®

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