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Monika Kawohl Statistical Programming Accovion GmbH

Tutorial: define.xml. Monika Kawohl Statistical Programming Accovion GmbH. Overview. Requirements Regulatory Technical define.xml Sections/Elements Process Flow at Accovion. Regulatory Requirements. eCTD‘s Study Data Specifications V1.5.1. ADaM. SDTM.

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Monika Kawohl Statistical Programming 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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