CDISC Open Source and low-cost Solutions

1
CDISC Open Sourceand 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 Designerdrag-and-drop
6
ODM Study Designerannotated eCRFs
7
ODM Study Designerannotated CRF as PDF
8
ODM Study Designerannotated CRF as PDF
9
ODM Study Designercomplete 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 3.1.1 and 3.1.2
• 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
OpenClinicaweb interface
13
OpenClinicainternationalization

• 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
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

16
OpenXDataOpen Source for mobile phone data
collection
17
OpenXDataOpen Source for mobile phone data
collection

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

18
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

19
CDISC ODM Checkerfree validation tool
20
CDISC ODM Checkerfree validation tool
21
SDTM-ETLTransformations from ODM to SDTM

• Low-cost (relative to SAS) for developing and
  execution transformations between operational
  data (ODM) and submission data (SDTM)
• 11, 1n and n1 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

22
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

23
SDTM-ETL
24
SDTM-ETL
25
SDTM-ETLNew in version 1.4

• Partial support for ADaM datasets and other
  non-SDTM datasets
• Mapping completeness reports
• Support for non-standard variables gt 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
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

30
OpenCDISC
31
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

32
SDTM datasets proposed formattingdefine 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 !