XML and define.xml Files in FDA Study Data Submission
FDA’s June 2026 conformance guide specifies .xml for XML files used in the covered study-data submission context and states that define.xml should not be compressed.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
Use the .xml extension for XML study-data files and follow the current FDA guidance for define.xml packaging, including the instruction not to compress define.xml.
Key details
Core IssueFDA’s June 2026 conformance guide specifies .xml for XML files used in the covered study-data submission context and states that define.xml should not be compressed.
Registerscholarly, professional, or research/report writing
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
Keep XML metadata packaging separate from the XPORT dataset-format canonical and recheck current FDA/eCTD specifications before applying version-sensitive packaging details.
Purpose
Use the .xml extension for XML study-data files and follow the current FDA guidance for define.xml packaging, including the instruction not to compress define.xml.
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 conformance guide states that SAS CPORT transport files cannot be processed, reviewed, or archived by FDA in the covered study-data submission workflow.
FDA’s June 2026 conformance guide sets maximum descriptor lengths of 8 characters for variable names and 40 characters for variable descriptive labels and dataset labels in the specified study-data exchange context. These numeric limits are current FDA technical-conformance specifications and should be rechecked when the guide or supported exchange format changes.
FDA’s June 2026 Study Data Technical Conformance Guide gives specific conventions for variable descriptive labels and dataset labels, including avoiding certain unbalanced punctuation that can interfere with processing. 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.
FDA’s June 2026 conformance guide requires variable and dataset names to follow the applicable standards-development-organization technical specifications and gives SAS naming-option guidance for submitted 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.
FDA’s June 2026 conformance guide recommends sizing character-data columns to the maximum variable length used across study datasets, with a separate individual-dataset rule for SUPPQUAL datasets. This is current FDA technical-conformance guidance for study-data files; exact implementation must still follow the applicable supported data standard and submission format.
