FDA’s June 2026 conformance guide states that the dataset contained in a transport file should be named the same as the transport file, making file-system naming a distinct submission-packaging requirement from variable and dataset syntax rules.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
For FDA XPORT submissions covered by the current conformance guide, keep the dataset name and transport-file name aligned as specified by the guide.
Key details
Core IssueFDA’s June 2026 conformance guide states that the dataset contained in a transport file should be named the same as the transport file, making file-system naming a distinct submission-packaging requirement from variable and dataset syntax rules.
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Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
Treat the transport-file mapping as a file-packaging rule; do not merge it with the separate rules governing variable names, dataset names inside standards, labels, or metadata.
Purpose
For FDA XPORT submissions covered by the current conformance guide, keep the dataset name and transport-file name aligned as specified by the guide.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
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