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

Outline Define.xml Generation Process Overview 4 Steps to Define.xml DefinedocTM Software Plain slide (no subtitle)

Define.xml Generation Process Overview Plain slide (no subtitle)

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 Plain slide (no subtitle)

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 Plain slide (no subtitle)

Final Define.xml Example Plain slide (no subtitle)

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) Plain slide (no subtitle)

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) Plain slide (no subtitle)

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) Plain slide (no subtitle)

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 Plain slide (no subtitle)

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) Plain slide (no subtitle)

DefinedocTM – Edit Definition Screen Define dataset metadata Define variable metadata Click on ‘Value Level‘ button to define value-level metadata Plain slide (no subtitle)

DefinedocTM – Edit Definition Screen Define dataset metadata Define variable metadata Click on ‘Value Level‘ button to define value-level metadata Plain slide (no subtitle)

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 Plain slide (no subtitle)

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) Plain slide (no subtitle)

Real people. Real results.® Final slide