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  1. XML Tech Home on the CDISC Portal
  2. XML Tech Home on the CDISC Wiki (Access may be restricted to Data Exchange Team Members)

Leadership Team

  • Sam Hume (co-lead)
  • Sally Cassells (co-lead)

Core Team Members:

  • Kevin Burges
  • Jozef Aerts
  • Lex Jansen
  • Marcelina Hungria
  • Mike Molter

Team Characteristics

Development Sub-Teams:

  • Dataset-XML
  • Define-XML IG / Validation Rules
  • Protocol-XML
  • CTR&R
  • SHARE XML Exports

Support for CDISC Metadata:

  • SDTM Metadata Submission Guide (Jozef Aerts & Marcelina Hungria)
  • ADaM Metadata (Sally Cassells & Lex Jansen)

Volunteers with an interest in XML and the CDISC standards are needed. XML expertise is not required.

Team Mission

The CDISC Data Exchange Team creates and maintains XML representations of CDISC standards. The Data Exchange Team also aids in the development of models that support the instantiation of standards in XML and other formats, such as RDF. The Data Exchange Team owns the ODM standard and is completely responsible for its development.

The Data Exchange Team has 6 production standards:

  • ODM v1.2, 1.3.1, and 1.3.2
  • Define-XML v1.0 and 2.0
  • Dataset-XML v1.0
  • SDM-XML v1.0
  • CT-XML v1.0


The Data Excjamge Team supports the development and maintenance of specifications for the acquisition, exchange and archive of clinical research metadata and data between systems and organizations.  Specifically, the team focuses on the development of XML Schemas, although it also supports other exchange formats such as RDF. The Data Exchange Team primarily focuses on specifications to support the use of CDISC Foundational Standards (PRM, SDM, CDASH, Lab, SDTM, SEND, ADaM, Controlled Terminology), though many of these XML standards can be used with other clinical data that do not necessarily conform to CDISC standards.

2015 Deliverables

  • Define-XML v2.1 (Q3)

  • Clinical Trials Registration (Q3)
  • Define-XML v2.x User Guide (Q4)

  • ODM v2.0 Requirements (Q4)

  • Protocol-XML v1.0 (2016)


  • Regulatory Authorities
  • Standards Development Organizations
  • Pharmaceutical Sponsors
  • Medical Devices, Diagnostics
  • Contract Research Organizations
  • Consultants
  • Software Providers
  • Healthcare IT
  • Academic Researchers
  • Biotechnology


Dependencies on Other Standards/Teams/SDOs/Organizations:

SDTM Metadata, SDTM Validation, ADaM Metadata, CDASH, PRG, SHARE, IHE, ISO, HL7, PhUSE



Operating Model & Meetings

Monthly full team meeting on the 3rd Tuesday of the month

Development sub-teams typically meet every two weeks.

Team portal repository:

1 Comment

  1. created new categories for trials. E.g., device-feasibility study as a type of interventional study. CTR-XML or the CDISC Controlled Terminology will have to udated to reflect those terms.