CDISC Standards for Clinical Data
FAMOUS: CDISC ODM Wiki
A series of articles about how to implement
the CDISC ODM Standard
(Clinical Data Interchange Standards Consortium) is establishing new
standards for exchange, storage, archival and submission of clinical data. These standards have
recently been acknowledged by the FDA. There most important of these standards are:
the ODM (Operational Data Model), the Lab standard and the
SDTM (Submission Data Model) and ADaM (Analysis Data Model), with others (like the Protocol Standard) coming up.
- The ODM standard describes a format in which clinical data are stored, exchanged or archived
- The Lab standard is used for exchange of laboratory data between labs and CROs
- The CRT-DDS (better known as define.xml) is a standard for providing data descriptions for Case Report Tabulations
in an XML format for submission to the FDA.
The promise of this standard is that submissions done using the CRT-DDS can be processed considerable faster by the regulatory authorities.
- THE CDASH standard harmonizes the content of (e)CRFs so that a 1:1 mapping with SDTM is almost possible
- The SDTM is a standard for describing the format in which clinical data should be submitted in electronic form to the FDA
- The ADaM is a standard for describing the format in which analysis clinical data should be submitted to the FDA
- The Protocol standard is a standard for describing the full protocol of a clinical trial. Important parts of the Protocol standard are currently
being implemented as a machine-readable format (based on ODM).
An overview of the CDISC standards can be found on the CDISC website
Our commitment to CDISC
XML4Pharma is an active volunteer in a number of the CDISC development teams. We are currently involved in the further development
of the ODM and the CRT-DDS (define.xml) standards, in the XML-ization of the Protocol standard, and have been active in the Compliance team.
We are also helping other teams with all kind of XML matters, such as the development of XML-Schema's.
Our services in relation to CDISC
XML4Pharma, as a firm believer in XML
technology, fully supports the CDISC-ODM, Lab and CRT-DDS (define.xml) and SDTM standards, and helps sponsors,
CROs and Data Management Companies and Technology Vendors with their implementation.
Important for us is knowledge transfer. We help our customers not only in the realisation of a project, but also in obtaining the necessary
knowledge to understand the CDISC standards, and to learn how to work with XML technologies.
- We help players in the clinical trials world with the implementation of the CDISC standards. This goes from consultancy to full development of
systems and software.
- We provide pharma and pharma-related companies with on-location, company-tailored courses and trainings
for working with CDISC XML-based standards (ODM, Lab, CRT-DDS (define.xml) and SDTM).
- For Technology Providers (but also for CROs and sponsors) we develop tailored software for enabling their systems to work with the CDISC standards.
For example, for a number of EDC vendors, we already developed and provided the necessary software to allow their systems to import and export data in CDISC
format (ODM, Lab), and for enabling their systems to become CDISC-compliant.
If your EDC system has the ability to import and export data in CDISC format, XML4Pharma may have implemented that !
- Furthermore we develop and provide standard software for working with the CDISC set of standards,
such as for validating XML files against the CDISC standards (ODM, Lab, define.xml), for setting up clinical studies,
and for visualization of CDISC-XML data files.
Some of our tools for working with the CDISC set of standards
Our demo application server for working with CDISC standards
CDISC Publications and Presentations
XML4Pharma, Schlossbergstr. 20, 78224 Singen, Germany. Phone: +49 7731 975044