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CDISC Open Source
and low-cost Solutions
Jozef Aerts
XML4Pharma
Topics
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Study design tools
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OpenClinica EDC
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OpenXData for clinical research
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CDISC ODM Checker
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SDTM generation: SDTM-ETL
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Define.xml Checker
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OpenCDISC
Study Design Tools
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XML4Pharma ODM Study Designer
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Low cost
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Single user design tool
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Reuse of design libraries
Formedix Origin Study Modeller
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Medium cost
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Collaboration tool
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Reuse of design libraries
ODM Study Designer
ODM Study Designer
drag-and-drop
ODM Study Designer
annotated eCRFs
ODM Study Designer
annotated CRF as PDF
ODM Study Designer
annotated CRF as PDF
ODM Study Designer
complete design as HTML/PDF
ODM Study Designer
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Supports any Vendor Extension
(incl. define.xml) “out of the box”
CDASH forms
SDTM annotation acc. SDTM-IG 3.1.1 and
3.1.2
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Annotations using “SDSVarName” and “Alias”
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Annotated eCRF
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Support for upcoming Protocol Extension
OpenClinica
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Open-Source EDC System from Akaza Res.
Very popular among academic institutions and
small CROs
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ODM 1.3 export
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Enterprise version for commercial customers
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Validation package
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Full support
Most important customer: NCI / caBIG
OpenClinica
web interface
OpenClinica
internationalization
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Translations (properties files) available for:
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French
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Spanish
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German
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Simple Chinese
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Italian
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Portuguese
Translations are developed by the community
OpenClinica and CDISC
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Evolution to have CDISC ODM as the base for
the architecture
ODM 1.3 export (metadata, clinical data)
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Special features as Vendor Extension
In future: SAS XPT export
OpenXData
Open Source for mobile phone data collection
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For primary care and clinical research
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System consists of:
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Web server
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Web form designer
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Mobile phones for offline and online data
collection
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Mobile phone forms based on XForms
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Interface developed with OpenClinica
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Initiative to generate forms directly from ODM
OpenXData
Open Source for mobile phone data collection
OpenXData
Open Source for mobile phone data collection
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Enormously successful in developing countries
(Pakistan, Ghana, Uganda, ...)
But also interesting for clinical research in
developed countries ?
CDISC ODM Checker
free validation tool

Freely available to CDISC members
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New version 1.3
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support for ODM 1.2 and 1.3
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new GUI
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Implements “Include” mechanism for
metadata version updates
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Reporting facilities
CDISC ODM Checker
free validation tool
CDISC ODM Checker
free validation tool
SDTM-ETL
Transformations from ODM to SDTM
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Low-cost (relative to SAS) for developing and
execution transformations between operational
data (ODM) and submission data (SDTM)
1:1, 1:n and n:1 mappings
Automated generation of (editable) mapping
scripts
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Many wizards and dialogs
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Implements SDTM-IG 3.1.1 and 3.1.2
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Automated generation of define.xml
SDTM-ETL
Transformations from ODM to SDTM
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Uses XSLT for SDTM records generation
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Allows SDTM database generation
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Generation of SAS datasets for SDTM
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SAS-free
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Further development of SDTMWandler
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Developed in cooperation with TMV e.V.
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Freely available for German institutions and
companies
SDTM-ETL
SDTM-ETL
SDTM-ETL
New in version 1.4
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Partial support for ADaM datasets and other nonSDTM datasets
Mapping completeness reports
Support for non-standard variables
=> SuppQual
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Improved searching and navigation facilities
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Extended define.xml views
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Incorporation of OpenCDISC for validation
Other low-cost (?) mapping tools
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XClinical Tabulator
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Formedix Submit
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Entimo entimICE
Define.xml Checker
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Low-cost validation tool for define.xml files
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Validates against the XML-Schema
+ all other rules from the specification
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Generation of validation reports (e.g. PDF)
Define.xml Checker
OpenCDISC
Open-source SDTM Validation
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Validation of SDTM datasets (SAS XPT) against
SDTM and Janus rules
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Version 1.0 from OpenCDISC.org
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SDTM-IG 3.1.1 and 3.1.2
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WebSDM rules implementation
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Additional user-defined rules validation
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define.xml validation
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(prototype) define.xml generation
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Interfacable with other software
OpenCDISC
What makes OpenCDISC
so interesting ?
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Rules are defined as Schematron-XML
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Are machine readable
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Everyone has the same rules – no different
interpretations possible
Opens the door for clear, unambigous rules for
SDTM
Now that HL7-XML for SDTM submissions is
“dying”, we aim for an SDTM format based on
define.xml
SDTM datasets proposed formatting
“define for data”

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SDTM metadata are submitted as define.xml
Why not submit SDTM data as XML using a
similar format ?
Advantages:
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Rules can be defined and published as
Schematron XML
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Get rid of all SAS XPT limitations
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SUPPQUAL almost becomes unnecessary

Stylesheets for viewing and validation can be
developed
Thank you Herzlichen Dank !