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CDISC Open Source and low-cost Solutions Jozef Aerts XML4Pharma.

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Presentation on theme: "CDISC Open Source and low-cost Solutions Jozef Aerts XML4Pharma."— Presentation transcript:

1 CDISC Open Source and low-cost Solutions Jozef Aerts XML4Pharma

2 Topics Study design tools OpenClinica EDC OpenXData for clinical research CDISC ODM Checker SDTM generation: SDTM-ETL Define.xml Checker OpenCDISC

3 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

4 ODM Study Designer

5 ODM Study Designer drag-and-drop

6 ODM Study Designer annotated eCRFs

7 ODM Study Designer annotated CRF as PDF


9 ODM Study Designer complete design as HTML/PDF

10 ODM Study Designer Supports any Vendor Extension (incl. define.xml) out of the box CDASH forms SDTM annotation acc. SDTM-IG and Annotations using SDSVarName and Alias Annotated eCRF Support for upcoming Protocol Extension

11 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

12 OpenClinica web interface

13 OpenClinica internationalization Translations (properties files) available for: French Spanish German Simple Chinese Italian Portuguese Translations are developed by the community

14 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

15 OpenXData Open 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

16 OpenXData Open Source for mobile phone data collection

17 Enormously successful in developing countries (Pakistan, Ghana, Uganda,...) But also interesting for clinical research in developed countries ?

18 CDISC ODM Checker free 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

19 CDISC ODM Checker free validation tool


21 SDTM-ETL Transformations 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 and Automated generation of define.xml

22 SDTM-ETL Transformations 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



25 SDTM-ETL New 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

26 Other low-cost (?) mapping tools XClinical Tabulator Formedix Submit Entimo entimICE

27 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)

28 Define.xml Checker

29 OpenCDISC Open-source SDTM Validation Validation of SDTM datasets (SAS XPT) against SDTM and Janus rules Version 1.0 from SDTM-IG and WebSDM rules implementation Additional user-defined rules validation define.xml validation (prototype) define.xml generation Interfacable with other software

30 OpenCDISC

31 What makes OpenCDISC so 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

32 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

33 Thank you - Herzlichen Dank !

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