CDISC Open Source and low-cost Solutions
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Transcript of CDISC Open Source and low-cost Solutions
CDISC Open Sourceand low-cost Solutions
Jozef AertsXML4Pharma
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 Single user design tool Reuse of design libraries
Formedix Origin Study Modeller Medium cost Collaboration tool Reuse of design libraries
ODM Study Designer
ODM Study Designerdrag-and-drop
ODM Study Designerannotated eCRFs
ODM Study Designerannotated CRF as PDF
ODM Study Designerannotated CRF as PDF
ODM Study Designercomplete design as HTML/PDF
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
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
OpenClinicaweb interface
OpenClinicainternationalization
Translations (properties files) available for: French Spanish German Simple Chinese Italian Portuguese
Translations are developed by the community
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
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
OpenXDataOpen Source for mobile phone data collection
OpenXDataOpen Source for mobile phone data collection
Enormously successful in developing countries(Pakistan, Ghana, Uganda, ...)
But also interesting for clinical research in developed countries ?
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
CDISC ODM Checkerfree validation tool
CDISC ODM Checkerfree validation tool
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
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
SDTM-ETL
SDTM-ETL
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
Other low-cost (?) mapping tools
XClinical Tabulator
Formedix Submit
Entimo entimICE
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)
Define.xml Checker
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
OpenCDISC
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
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
Thank you - Herzlichen Dank !