Regulatory Compliance Overview

xportrs is designed to produce XPT files that meet the requirements of major regulatory agencies for clinical trial data submissions.

Supported Agencies

Agency	Region	Standards	xportrs Support
FDA	United States	CDISC SDTM/ADaM	Full validation
PMDA	Japan	CDISC + J-SDTM extensions	Full validation
NMPA	China	CDISC + local requirements	Full validation
EMA	Europe	CDISC SDTM/ADaM	Full validation

Key Requirements

All agencies require XPT V5 format files that conform to the SAS Transport specification (TS-140). The key requirements are:

Variable Requirements

graph LR
subgraph "Variable Constraints"
A[Name ≤8 bytes] --> B[Uppercase A-Z, 0-9, _]
B --> C[Must start with letter]
D[Label ≤40 bytes] --> E[ASCII only for FDA]
F[Char length ≤200] --> G[Numeric = 8 bytes]
end

Dataset Requirements

Dataset name: 1-8 bytes, uppercase alphanumeric
Dataset label: 0-40 bytes (recommended for reviewer clarity)
File size: ≤5GB per file (auto-split supported)

Format Requirements

XPT files must use:

IBM floating-point encoding (not IEEE 754)
Big-endian byte order
SAS epoch (January 1, 1960) for dates
80-byte records for headers

Validation Levels

xportrs provides three severity levels for validation issues:

Severity	Meaning	Example
Error	File will not be accepted	Variable name >8 bytes
Warning	Review recommended	Missing variable label
Info	Best practice suggestion	Non-standard format

[!IMPORTANT] Only Error severity issues block file writing. Warnings and info messages are advisory.

Agency-Specific Rules

FDA (United States)

The FDA requires strict ASCII compliance for all text:

#![allow(unused)]
fn main() {
use xportrs::{Agency, Xpt};

let validated = Xpt::writer(dataset)
.agency(Agency::FDA)
.finalize() ?;

// Check for FDA-specific issues
for issue in validated.issues() {
println ! ("[{}] {}", issue.severity(), issue);
}
}

PMDA (Japan)

PMDA allows Shift-JIS encoding for Japanese text in certain fields:

#![allow(unused)]
fn main() {
use xportrs::{Agency, TextMode, Xpt};

let validated = Xpt::writer(dataset)
.agency(Agency::PMDA)
.text_mode(TextMode::Latin1)  // Extended character support
.finalize() ?;
}

NMPA (China)

NMPA follows CDISC standards with additional local requirements:

#![allow(unused)]
fn main() {
use xportrs::{Agency, Xpt};

let validated = Xpt::writer(dataset)
.agency(Agency::NMPA)
.finalize() ?;
}

Compliance Verification

Using xportrs Validation

#![allow(unused)]
fn main() {
let validated = Xpt::writer(dataset)
.agency(Agency::FDA)
.finalize() ?;

// Count issues by severity
let errors = validated.issues().iter()
.filter( | i| i.severity() == Severity::Error)
.count();

if errors > 0 {
eprintln ! ("{} blocking errors found", errors);
}
}

External Validation (Pinnacle 21)

After generating XPT files, we recommend validation with Pinnacle 21 Community:

Download from Pinnacle 21
Run validation against your XPT files and define.xml
Review any SD (Study Data) rule violations

[!NOTE] xportrs handles XPT-level compliance. Dataset content validation (controlled terminology, required variables) requires external tools like Pinnacle 21.

xportrs Documentation