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 !