Exporting Data

After mapping and validation, export your data to CDISC-compliant formats.

Export Formats

Trial Submission Studio supports multiple output formats:

XPT Export

XPT Version 5 (Default)

The FDA standard format with these constraints:

• Variable names: 8 characters max
• Labels: 40 characters max
• Compatible with SAS V5 Transport

XPT Version 8

Extended format supporting:

• Variable names: 32 characters
• Labels: 256 characters
• Note: Not all systems support V8

Export Steps

1. Click Export in the toolbar
2. Select XPT V5 or XPT V8
3. Choose output location
4. Click Save

XPT Options

Dataset-XML Export

CDISC ODM-based XML format for data exchange.

Features

• Human-readable format
• Full Unicode support
• Metadata included
• Schema validation

Export Steps

1. Click Export
2. Select Dataset-XML
3. Configure options
4. Click Save

Define-XML Export

Generate submission metadata documentation.

Define-XML 2.1

• Dataset definitions
• Variable metadata
• Controlled terminology
• Computational methods
• Value-level metadata

Export Steps

1. Click Export
2. Select Define-XML
3. Review metadata
4. Click Save

Batch Export

Export multiple domains at once:

1. File → Batch Export
2. Select domains to export
3. Choose format(s)
4. Set output directory
5. Click Export All

Export Validation

Before export completes, the system verifies:

• All required variables are present
• Data types are correct
• Lengths don’t exceed limits
• Controlled terms are valid

Output Files

File Naming

Default naming convention:

• {domain}.xpt - e.g., dm.xpt, ae.xpt
• {domain}.xml - for Dataset-XML
• define.xml - for Define-XML

Checksums

Each export generates:

• SHA256 checksum file (.sha256)
• Useful for submission verification

Quality Checks

Post-Export Verification

1. Open the exported file in a viewer
2. Verify row counts match
3. Check variable order
4. Review sample values

External Validation

Consider validating with:

• Pinnacle 21 Community
• SAS (if available)
• Other CDISC validators

Best Practices

1. Validate before export - Fix all errors first
2. Use XPT V5 for FDA - Standard format
3. Generate checksums - For integrity verification
4. Test with validators - Confirm compliance
5. Keep source files - Maintain audit trail

Troubleshooting

Export Fails

Output Issues

Next Steps

• Common Workflows - End-to-end examples
• XPT Format - XPT specification
• Define-XML - Define-XML guide