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

2. Overview Requirements Regulatory Technical
define.xml Sections/Elements
Process Flow at Accovion
CDISC German Speaking User Group Meeting, 11-Mar-2010

3. Regulatory Requirements
20/05/2018
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 ?
CDISC German Speaking User Group Meeting, 11-Mar-2010

4. Why define.xml Benefit of define.xml not restricted to submissions
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
CDISC German Speaking User Group Meeting, 11-Mar-2010

5. CDISC German Speaking User Group Meeting, 11-Mar-2010

6. CDISC German Speaking User Group Meeting, 11-Mar-2010

7. XML Basics Schema (extension: .XSD) XML File (extension: .XML)
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
CDISC German Speaking User Group Meeting, 11-Mar-2010

8. Advantages of XML – Basic Technology
<?xml version="1.0" encoding="ISO "?>
<?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
CDISC German Speaking User Group Meeting, 11-Mar-2010

9. 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
CDISC German Speaking User Group Meeting, 11-Mar-2010

10. Data Metadata
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11. Variable Metadata
Change for Origin in SDTM IG 3.1.2: Sponsor Defined, Assigned, eDT, Protocol
CDISC German Speaking User Group Meeting, 11-Mar-2010

12. 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>
CDISC German Speaking User Group Meeting, 11-Mar-2010

13. Variable Value Level Metadata
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14. Computational Algorithms
Complex Derivations
Derivations Used More than Once
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15. Controlled Terminology/Code Lists
External dictionary references incl. versions
e.g., MEDDRA, WHODRUG
CDISC German Speaking User Group Meeting, 11-Mar-2010

16. 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
CDISC German Speaking User Group Meeting, 11-Mar-2010

17. SDTM Process Flow at Accovion
Annotated CRF
Specifications
define.xml (SDTM)
Mapping
programs
SDTM
= dataset templates
= source for define.xml
red: e-submission deliverables
Communication
CDISC German Speaking User Group Meeting, 11-Mar-2010

18. ADaM Process Flow at Accovion
define.xml (ADaM)
ADaM Specifications
Datasets
creation
programs
- Analysis datasets
ADaM
SDTM
SAP
= dataset templates
Results
creation
programs
- Analysis results
Analysis
results
(TLGs)
red: (potential) e-submission deliverables
source for define.xml
Communication
CDISC German Speaking User Group Meeting, 11-Mar-2010

19. References CDISC Website (http://www.cdisc.org/)
CRT-DDS (define.xml) standard V1.0 (
Metadata Submission Guidelines, Appendix to SDTM IG V3.1.1 (
CDISC SDTM/ADaM Pilot (sample submission package) (
eCTD‘s Study Data Specifications V ( msSubmissionRequirements/ElectronicSubmissions/UCM pdf)
CDISC German Speaking User Group Meeting, 11-Mar-2010

20. Thank you! Questions?
Contact Information: Monika Kawohl Senior Statistical Programmer Accovion GmbH Softwarecenter Marburg Germany Phone: Fax:
CDISC German Speaking User Group Meeting, 11-Mar-2010