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Dataset-XML

Dataset-XML supports exchanging tabular data in clinical research applications using ODM-based XML technologies, enabling communication of study results and regulatory submissions. Dataset-XML is a truly non-proprietary, global standard, removing many SAS V5 Transport file restrictions, such as 8-character variable names and 200-character text fields.

CDISC developed Dataset-XML v1.0 as a drop-in replacement for SAS V5 XPORT to enable testing using existing processes. New Dataset-XML features were intentionally not implemented to simplify the comparison. Now that Dataset-XML v1.0 has been shown to work as a SAS V5 XPORT replacement, the CDISC XML Technologies Team will add additional features in the next versions, including improved relationships and traceability.

 

Dataset-XML can represent any tabular dataset including SDTM, ADaM, SEND, or non-standard legacy datasets. Noteworthy items relating to Dataset-XML v1.0 include:

  • Alternative to SAS Version 5 Transport (XPORT) format for datasets
  • ODM-based model for representation of SEND, SDTM, ADaM or legacy datasets
  • Capable of supporting CDISC regulatory data submissions
  • Based on Define-XML v2 or v1 metadata, easy to reference
  • Dataset-XML supports all language encodings supported by XML

For information on tool support, visit http://wiki.cdisc.org/display/PUB/CDISC+Dataset-XML+Resources

The FDA completed a "Transport Format for the Submission of Regulatory Study Data” Dataset-XML Pilot and has posted the resulting test report on their web site

Dataset-XML v1.0

1.0.1
22 Apr 2014

Dataset-XML supports exchanging tabular data in clinical research applications using ODM-based XML technologies, enabling communication of study results and regulatory submissions. Dataset-XML is a truly non-proprietary, global standard, removing many SAS V5 Transport file restrictions, such as 8-character variable names and 200-character text fields.

CDISC developed Dataset-XML v1.0 as a drop-in replacement for SAS V5 XPORT to enable testing using existing processes. New Dataset-XML features were intentionally not implemented to simplify the comparison. Now that Dataset-XML v1.0 has been shown to work as a SAS V5 XPORT replacement, the CDISC XML Technologies Team will add additional features in the next versions, including improved relationships and traceability.

Dataset-XML can represent any tabular dataset including SDTM, ADaM, SEND, or non-standard legacy datasets. Noteworthy items relating to Dataset-XML v1.0 include:

  • Alternative to SAS Version 5 Transport (XPORT) format for datasets

  • ODM-based model for representation of SEND, SDTM, ADaM or legacy datasets

  • Capable of supporting CDISC regulatory data submissions

  • Based on Define-XML v2 or v1 metadata, easy to reference

  • Dataset-XML supports all language encodings supported by XML

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Package icon Dataset-XML v1.01.41 MB