cdisc open source and low-cost solutions
DESCRIPTION
CDISC Open Source and low-cost Solutions. Jozef Aerts XML4Pharma. Topics. Study design tools OpenClinica EDC OpenXData for clinical research CDISC ODM Checker SDTM generation: SDTM-ETL Define.xml Checker OpenCDISC. Study Design Tools. XML4Pharma ODM Study Designer Low cost - PowerPoint PPT PresentationTRANSCRIPT
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CDISC Open Sourceand low-cost Solutions
Jozef AertsXML4Pharma
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Topics
Study design tools OpenClinica EDC OpenXData for clinical research CDISC ODM Checker SDTM generation: SDTM-ETL Define.xml Checker OpenCDISC
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Study Design Tools
XML4Pharma ODM Study Designer Low cost Single user design tool Reuse of design libraries
Formedix Origin Study Modeller Medium cost Collaboration tool Reuse of design libraries
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ODM Study Designer
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ODM Study Designerdrag-and-drop
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ODM Study Designerannotated eCRFs
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ODM Study Designerannotated CRF as PDF
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ODM Study Designerannotated CRF as PDF
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ODM Study Designercomplete design as HTML/PDF
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ODM Study Designer
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 Annotations using “SDSVarName” and “Alias” Annotated eCRF Support for upcoming Protocol Extension
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OpenClinica
Open-Source EDC System from Akaza Res. Very popular among academic institutions and
small CROs ODM 1.3 export
Enterprise version for commercial customers Validation package Full support
Most important customer: NCI / caBIG
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OpenClinicaweb interface
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OpenClinicainternationalization
Translations (properties files) available for: French Spanish German Simple Chinese Italian Portuguese
Translations are developed by the community
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OpenClinica and CDISC
Evolution to have CDISC ODM as the base for the architecture
ODM 1.3 export (metadata, clinical data) Special features as Vendor Extension
In future: SAS XPT export
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OpenXDataOpen Source for mobile phone data collection
For primary care and clinical research System consists of:
Web server Web form designer Mobile phones for offline and online data
collection Mobile phone forms based on XForms Interface developed with OpenClinica Initiative to generate forms directly from ODM
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OpenXDataOpen Source for mobile phone data collection
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OpenXDataOpen Source for mobile phone data collection
Enormously successful in developing countries(Pakistan, Ghana, Uganda, ...)
But also interesting for clinical research in developed countries ?
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CDISC ODM Checkerfree validation tool
Freely available to CDISC members New version 1.3
support for ODM 1.2 and 1.3 new GUI Implements “Include” mechanism for metadata
version updates Reporting facilities
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CDISC ODM Checkerfree validation tool
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CDISC ODM Checkerfree validation tool
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SDTM-ETLTransformations from ODM to SDTM
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 Many wizards and dialogs Implements SDTM-IG 3.1.1 and 3.1.2 Automated generation of define.xml
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SDTM-ETLTransformations from ODM to SDTM
Uses XSLT for SDTM records generation Allows SDTM database generation Generation of SAS datasets for SDTM SAS-free
Further development of SDTMWandler Developed in cooperation with TMV e.V. Freely available for German institutions and
companies
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SDTM-ETL
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SDTM-ETL
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SDTM-ETLNew in version 1.4
Partial support for ADaM datasets and other non-SDTM datasets
Mapping completeness reports Support for non-standard variables
=> SuppQual Improved searching and navigation facilities Extended define.xml views Incorporation of OpenCDISC for validation
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Other low-cost (?) mapping tools
XClinical Tabulator
Formedix Submit
Entimo entimICE
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Define.xml Checker
Low-cost validation tool for define.xml files Validates against the XML-Schema
+ all other rules from the specification Generation of validation reports (e.g. PDF)
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Define.xml Checker
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OpenCDISCOpen-source SDTM Validation
Validation of SDTM datasets (SAS XPT) against SDTM and Janus rules
Version 1.0 from OpenCDISC.org SDTM-IG 3.1.1 and 3.1.2 WebSDM rules implementation Additional user-defined rules validation define.xml validation (prototype) define.xml generation Interfacable with other software
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OpenCDISC
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What makes OpenCDISCso interesting ?
Rules are defined as Schematron-XML Are machine readable 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
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SDTM datasets proposed formatting“define for data”
SDTM metadata are submitted as define.xml Why not submit SDTM data as XML using a
similar format ? Advantages:
Rules can be defined and published as Schematron XML
Get rid of all SAS XPT limitations SUPPQUAL almost becomes unnecessary Stylesheets for viewing and validation can be
developed
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Thank you - Herzlichen Dank !