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CDISC Standards for Clinical Data

A series of articles about how to implement
the CDISC ODM Standard

CDISC (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

XML4Pharma is a CDISC Registered Solutions Provider

XML4Pharma is a CDISC Registered Solutions Provider

Since May 2003, XML4Pharma is being certified by CDISC as a "Registered Solutions Provider", meaning that CDISC endorses that XML4Pharma is qualified to provide assistance to organizations in implementing CDISC standards.
With this certification, the first in Europe, CDISC recognises our competence in implementing the CDISC ODM, SDTM, CDASH and Lab standards, used for exchange, archival and submission of clinical trial data. It also recognises our work in developing CDISC compliant software tools.

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.

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

Contact XML4Pharma
XML4Pharma, Katzelbachweg 18, 8052 Thal, Austria