Changelog

All notable changes to Trial Submission Studio.

The format is based on Keep a Changelog, and this project adheres to Semantic Versioning.

Unreleased

Added

• Initial mdBook documentation site
• Comprehensive user guide
• CDISC standards reference
• Architecture documentation
• Contributing guidelines

Changed

• Updated documentation structure

Fixed

• Various documentation improvements

0.0.1-alpha.1 - 2024-XX-XX

Added

Core Features

• CSV file import with automatic schema detection
• Column-to-SDTM variable mapping with fuzzy matching
• XPT V5 and V8 export support
• Basic SDTM validation
• Controlled terminology validation

Standards Support

• SDTM-IG v3.4 embedded
• Controlled Terminology 2024 versions
• Domain definitions for common SDTM domains

User Interface

• Native desktop GUI (egui/eframe)
• Data preview grid
• Mapping interface with suggestions
• Validation results panel
• Export options dialog

Platform Support

• macOS (Apple Silicon)
• macOS (Intel)
• Windows (x86_64)
• Windows (ARM64)
• Linux (x86_64)

Known Issues

• Alpha software - not for production use
• ADaM support not yet implemented
• SEND support not yet implemented
• Dataset-XML export in progress
• Define-XML export in progress

Version History

Release Notes Format

Each release includes:

• Added - New features
• Changed - Changes to existing features
• Deprecated - Features to be removed
• Removed - Removed features
• Fixed - Bug fixes
• Security - Security fixes

Getting Updates

Check for Updates

Trial Submission Studio checks for updates automatically. You can also:

1. Visit GitHub Releases
2. Download the latest version for your platform
3. Replace your existing installation

Update Notifications

When a new version is available, you’ll see a notification in the application.

Reporting Issues

Found a bug or have a feature request?

• GitHub Issues
• GitHub Discussions