Keyboard shortcuts

Press ← or → to navigate between chapters

Press S or / to search in the book

Press ? to show this help

Press Esc to hide this help

Dataset-XML Format

Dataset-XML is a CDISC standard XML format for clinical data exchange.

Overview

Dataset-XML provides:

  • Human-readable data format
  • Full Unicode support
  • Embedded metadata
  • Alternative to XPT binary format

When to Use Dataset-XML

Use CaseRecommendation
FDA submissionUse XPT (required)
Internal data exchangeDataset-XML works well
Archive/audit trailGood for documentation
Non-SAS environmentsEasier integration
Full character supportUnicode capable

Format Structure

ODM Container

Dataset-XML is based on CDISC ODM (Operational Data Model):

<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v1.3"
     xmlns:data="http://www.cdisc.org/ns/Dataset-XML/v1.0"
     FileType="Snapshot">
    <ClinicalData StudyOID="..." MetaDataVersionOID="...">
        <SubjectData SubjectKey="...">
            <StudyEventData StudyEventOID="...">
                <ItemGroupData ItemGroupOID="DM">
                    <ItemData ItemOID="STUDYID">ABC123</ItemData>
                    <ItemData ItemOID="USUBJID">ABC123-001</ItemData>
                    <!-- More items -->
                </ItemGroupData>
            </StudyEventData>
        </SubjectData>
    </ClinicalData>
</ODM>

Key Elements

ElementDescription
ODMRoot container
ClinicalDataStudy data container
SubjectDataPer-subject data
ItemGroupDataDomain records
ItemDataIndividual values

Creating Dataset-XML

Export Steps

  1. Complete data mapping
  2. Run validation
  3. Click Export → Dataset-XML
  4. Configure options
  5. Choose output location
  6. Click Save

Export Options

OptionDescription
Include metadataEmbed variable definitions
Pretty printFormat XML for readability
CompressReduce file size
Single fileOne file vs. file per domain

Dataset-XML vs XPT

AspectDataset-XMLXPT
FormatText (XML)Binary
ReadabilityHuman-readableRequires tools
SizeLargerSmaller
UnicodeFull supportLimited
FDA submissionAcceptedRequired
IntegrationEasierSAS-focused

Advantages

Human Readable

  • Open in any text editor
  • Easily inspectable
  • Good for debugging

Full Unicode

  • International characters
  • Special symbols
  • No character limitations

Self-Describing

  • Metadata embedded
  • Schema validation
  • No external dependencies

Platform Independent

  • Standard XML format
  • Any programming language
  • No proprietary tools needed

Limitations

File Size

  • Larger than binary XPT
  • Compression recommended for large datasets

FDA Preference

  • FDA prefers XPT for submissions
  • Dataset-XML accepted but less common

Processing Overhead

  • XML parsing slower than binary
  • More memory for large files

Validation

Schema Validation

Dataset-XML can be validated against:

  • CDISC Dataset-XML schema
  • ODM schema
  • Custom validation rules

Common Checks

  • Well-formed XML
  • Valid element structure
  • Data type conformance
  • Required elements present

Working with Dataset-XML

Reading Files

Dataset-XML can be read by:

  • Any XML parser
  • CDISC-compatible tools
  • Statistical software with XML support

Converting to Other Formats

From Dataset-XML, you can convert to:

  • XPT (for FDA submission)
  • CSV (for analysis)
  • Database tables

Technical Details

Encoding

  • UTF-8 (default and recommended)
  • UTF-16 supported
  • Encoding declared in XML header

Namespaces

xmlns="http://www.cdisc.org/ns/odm/v1.3"
        xmlns:data="http://www.cdisc.org/ns/Dataset-XML/v1.0"

File Extension

  • .xml for Dataset-XML files
  • Optionally: domain.xml (e.g., dm.xml)

Next Steps