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 Single user design tool Reuse of design libraries Formedix Origin Study Modeller Medium cost Collaboration tool

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 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

OpenClinica web interface

OpenClinica internationalization 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

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

OpenXData Open Source for mobile phone data collection

OpenXData Open 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 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

CDISC ODM Checker free validation tool

CDISC ODM Checker free validation tool

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 3.1.1 and 3.1.2 Automated generation of define.xml

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

SDTM-ETL

SDTM-ETL

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

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

OpenCDISC Open-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 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

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 !