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Tutorial on Define.xml for Statistical Programming at Accovion GmbH

Learn the importance of Define.xml in statistical programming including regulatory and technical aspects. Discover how to create and use Define.xml for data consistency checks and metadata. Understand XML basics and advantages. Explore SDTM and ADaM specifications with dataset documentation and metadata submission guidelines.

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Tutorial on Define.xml for Statistical Programming at Accovion GmbH

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  1. Tutorial:define.xml Monika Kawohl Statistical Programming Accovion GmbH

  2. Overview • Requirements • Regulatory • Technical • define.xml Sections/Elements • Process Flow at Accovion

  3. Regulatory Requirements • eCTD‘s Study Data Specifications V1.5.1 ADaM SDTM • “Dataset documentation includes data definitions and annotated case report forms.” • SDTM: define.xml • ADaM: define.pdf / define.xml ?

  4. Why define.xml • Metadata = data about data • Human-readable description to familiarize with data • What is included? • Where does the data come from? • Derivation rules, if applicable • Machine-readable metadata to facilitate ... • SDTM data consistency check • Upload into JANUS data warehouse • Preferred => mandatory format: define.xml • Benefit of define.xml not restricted to submissions

  5. XML Basics • Schema (extension: .XSD) • Declaration of elements and their attributes • Prerequisite for machine-readability • XML File (extension: .XML) • Data and metadata in machine-readable format • Usage of elements and attributes as defined in schema • Style Sheet (extension: .XSL) • Definition of layout in browser tool for Human-Readability • Usage of elements and attributes as defined in schema

  6. style sheet reference Advantages of XML – Basic Technology <?xml version="1.0" encoding="ISO-8859-1"?> <?xml-stylesheet type="text/xsl" href="define1-0-0.xsl"?> <ODM ... <ItemGroupDef OID="DM" Name="DM" Repeating="No" IsReferenceData="No" Purpose="Tabulation" def:Label="Demographics" def:Structure="One record per subject" def:DomainKeys="STUDYID, USUBJID" def:Class="Special Purpose" def:ArchiveLocationID="Location.DM"> ...

  7. define.xml Sections/Elements • Data Metadata (TOC) • Variable Metadata • Variable Value Level Metadata • (Computational Algorithms) • Controlled Terminology/Code Lists • Annotated CRF • Optional: Supplemental Data Definition Document • Navigation via Bookmarks and Hyperlinks

  8. Data Metadata

  9. Variable Metadata Change for Origin in SDTM IG 3.1.2: Sponsor Defined, Assigned, eDT, Protocol

  10. Variable Metadata – XML Code <ItemGroupDef OID="LB" ... <ItemRef ItemOID="LB.LBTESTCD" OrderNumber="5" Mandatory="Yes" Role="Topic"/> ... <ItemRef ItemOID="LB.LBBLFL" OrderNumber="22" Mandatory="No" Role="Record Qualifier"/> </ItemGroupDef> ... <ItemDef OID="LB.LBTESTCD" Name="LBTESTCD" DataType="text" Length="8" Origin="CRF Pages 5, 10, 15, 20" Comment="" def:Label="LAB Test or Examination Short Name"> <def:ValueListRef ValueListOID="ValueList.LB.LBTESTCD"/> </ItemDef> ... <ItemDef OID="LB.LBBLFL" Name="LBBLFL" DataType="text" Length="1" Origin="Derived"def:Label="Baseline Flag" def:ComputationMethodOID="COMPMETHOD.LBBLFL"> <CodeListRef CodeListOID="YF"/> </ItemDef>

  11. Variable Value Level Metadata

  12. Computational Algorithms • Complex Derivations • Derivations Used More than Once

  13. Controlled Terminology/Code Lists • External dictionary references incl. versions • e.g., MEDDRA, WHODRUG

  14. Annotated CRF (blankcrf.pdf) • See Draft CDISC Metadata Submission Guidelines • Annotate unique pages, reference from repeat pages • Annotate variables, variables values (cf. value level metadata) • Mark items that are not submitted

  15. Specifications AnnotatedCRF define.xml (SDTM) Mapping programs SDTM Communication SDTM Process Flow at Accovion = dataset templates = source for define.xml red: e-submission deliverables

  16. ADaM Specifications Datasets creation programs - Analysis datasets define.xml (ADaM) ADaM - Analysis results Results creation programs SAP SDTM Analysis results (TLGs) source for define.xml Communication ADaM Process Flow at Accovion = dataset templates red: (potential) e-submission deliverables

  17. References • CDISC Website(http://www.cdisc.org/) • CRT-DDS (define.xml) standard V1.0(http://www.cdisc.org/models/def/v1.0/index.html) • Metadata Submission Guidelines, Appendix to SDTM IG V3.1.1(http://www.cdisc.org/content1210) • CDISC SDTM/ADaM Pilot (sample submission package)(http://www.cdisc.org/content1037) • eCTD‘s Study Data Specifications V1.5.1(http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM199759.pdf)

  18. Thank you!Questions? Contact Information:Monika Kawohl Senior Statistical ProgrammerAccovion GmbH Softwarecenter 3 35037 Marburg Germany Phone: +49-6421-94849-20 Fax: +49-6421-94849-61Email: monika.kawohl@accovion.com

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