Official Sources
This page lists authoritative sources for XPT format and regulatory requirements.
SAS Documentation
TS-140: XPT V5 Specification
The authoritative specification for XPT V5 format.
- Title: Record Layout of a SAS Version 5 or 6 Data Set in SAS Transport (XPORT) Format
- Publisher: SAS Institute Inc.
- Link: TS-140 PDF
Key contents:
- File structure (headers, NAMESTR, observations)
- 140-byte NAMESTR record layout
- IBM floating-point encoding
- Character encoding rules
FDA Documentation
Study Data Technical Conformance Guide
Requirements for electronic study data submissions.
- Publisher: U.S. Food and Drug Administration
- Link: TCG PDF
Key contents:
FDA Data Standards Catalog
Supported CDISC standards and versions.
- Link: Data Standards Resources
CDISC Standards
SDTM Implementation Guide
Standard for tabulation data structure.
- Publisher: CDISC
- Link: SDTM-IG
Key contents:
- Domain structures (DM, AE, LB, etc.)
- Variable naming conventions
- Controlled terminology requirements
- Metadata requirements
ADaM Implementation Guide
Standard for analysis datasets.
- Publisher: CDISC
- Link: ADaM-IG
Key contents:
- Analysis dataset structures
- Derived variable conventions
- Traceability requirements
CDISC Controlled Terminology
Standard coded values for CDISC variables.
- Link: CDISC CT
Format Registries
Library of Congress
Format documentation and preservation information.
- XPT Format Family: FDD 000464
- XPT V5 Specific: FDD 000466
Validation Tools
Pinnacle 21
Industry-standard CDISC validation tool.
- Publisher: Certara
- Link: Pinnacle 21
Validates:
- XPT file structure
- CDISC standard compliance
- define.xml consistency
- Controlled terminology
OpenCDISC (Legacy)
Open-source validation (now Pinnacle 21 Community).
- Link: Community Downloads
International Regulators
PMDA (Japan)
NMPA (China)
- Link: NMPA Drug Center
EMA (Europe)
- Link: EMA eSubmission
Technical References
IBM Floating-Point
- Wikipedia: IBM Hexadecimal Floating-Point
- IBM Documentation: System/360 Principles
ISO 8601 Date/Time
- Standard: ISO 8601
Used for SDTM timing variables (--DTC).
Character Encodings
- ASCII: ANSI X3.4
- Latin-1: ISO/IEC 8859-1
Related Tools
xportr (R Package)
R package for XPT file handling:
- Link: xportr on GitHub
- Docs: xportr Documentation
pyreadstat (Python)
Python library for reading statistical file formats:
- Link: pyreadstat
haven (R Package)
R package for reading SAS files:
- Link: haven
Citation
When referencing xportrs in academic or regulatory contexts:
@software{xportrs,
title = {xportrs: SAS Transport (XPT) file format library for Rust},
author = {xportrs contributors},
year = {2024},
url = {https://github.com/rubentalstra/xportrs},
license = {MIT OR Apache-2.0},
}