Transcript CDISC Open Source and low

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

Reuse of design libraries
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 nonSDTM 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 !