FDA’s June 2026 conformance guide specifies SAS XPORT Version 5 transport format for electronic datasets in the covered FDA study-data submission context and gives file-level conventions for those datasets. These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use the currently required SAS XPORT Version 5 transport format and associated .xpt file conventions when the FDA submission guidance calls for that exchange format.
Key details
Core IssueFDA’s June 2026 conformance guide specifies SAS XPORT Version 5 transport format for electronic datasets in the covered FDA study-data submission context and gives file-level conventions for those datasets.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
These requirements are current FDA technical-conformance guidance for electronic study-data submissions and should be rechecked when FDA guidance, supported standards, or eCTD specifications change.
Further guidance
Content
This page concerns the exchange file format; it does not replace model-specific SDTM, ADaM, SEND, metadata, or controlled-terminology requirements.
Purpose
Use the currently required SAS XPORT Version 5 transport format and associated .xpt file conventions when the FDA submission guidance calls for that exchange format.
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.
FDA’s June 2026 guide describes the DD (Death Details) domain for supplemental information collected when a death occurs and expects consistency with relevant AE-domain death variables.
FDA’s June 2026 conformance guide says screen failures, when provided, should be represented as a DM record with specified planned/actual arm fields left blank.
FDA’s June 2026 guide gives DS-domain handling for multiple disposition events, including use of EPOCH or DSSCAT and a specific final-record convention for death.
FDA’s June 2026 guide explicitly calls for the DV domain in submissions containing protocol-deviation data and identifies review-oriented variables beyond CDISC-required fields.
FDA’s June 2026 guide gives a direct placement rule for viral-load results in standardized clinical study data: place them in the MB (Microbiology) domain.
