Monika Kawohl

Statistical Programming

Accovion GmbH

Tutorial:define.xml

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Overview Requirements

• Regulatory

• Technical

define.xml Sections/Elements

Process Flow at Accovion

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Regulatory Requirements

eCTD‘s Study Data Specifications V1.5.1

SDTM

“Dataset documentation includes data definitions and annotated case report forms.”

• SDTM: define.xml

• ADaM: define.pdf / define.xml ?

ADaM

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Why define.xmlMetadata = 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

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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

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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"> ...

style sheet

reference

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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

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Data Metadata

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Variable Metadata

Change for Origin in SDTM IG 3.1.2: Sponsor Defined, Assigned, eDT, Protocol

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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>

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Variable Value Level Metadata

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Computational Algorithms

Complex Derivations

Derivations Used More than Once

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Controlled Terminology/Code Lists

External dictionary references incl. versions

• e.g., MEDDRA, WHODRUG

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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

Annotated CRF (blankcrf.pdf)

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SDTM Process Flow at Accovion

Annotated CRF

Communication

= dataset templates

= source for define.xml

SDTM

red: e-submission deliverables

Specifications

Mapping

programs

define.xml (SDTM)

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ADaM Process Flow at Accovion

Communication

SDTM

SAP

ADaM

Results

creation

programs

Analysis

results

(TLGs)

- Analysis datasets

- Analysis results

= dataset templates

source for define.xml

define.xml (ADaM)

Datasets

creation

programs

ADaM Specifications

red: (potential) e-submission deliverables

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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)

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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