Disclaimer

Important notices about Trial Submission Studio.

Alpha Software Notice

Warning

Trial Submission Studio is currently in alpha development.

This software is provided for evaluation and development purposes only. It is not yet suitable for production use in regulatory submissions.

What This Means

• Features may be incomplete or change without notice
• Bugs and unexpected behavior may occur
• Data outputs should be independently validated
• No guarantee of regulatory compliance

Not for Production Submissions

Do not use Trial Submission Studio outputs for actual FDA, PMDA, or other regulatory submissions until the software reaches stable release (version 1.0.0 or later).

Before Submission

All outputs from Trial Submission Studio should be:

1. Validated by qualified regulatory professionals
2. Verified against CDISC standards independently
3. Reviewed for completeness and accuracy
4. Tested with regulatory authority validation tools

Limitation of Liability

Trial Submission Studio is provided “as is” without warranty of any kind, express or implied. The authors and contributors:

• Make no guarantees about output accuracy
• Are not responsible for submission rejections
• Cannot be held liable for regulatory issues
• Do not provide regulatory consulting

See the full MIT License for complete terms.

CDISC Standards

Trial Submission Studio implements CDISC standards based on publicly available documentation:

• SDTM-IG v3.4 - Study Data Tabulation Model Implementation Guide
• Controlled Terminology - 2024-2025 versions

CDISC standards are developed by the Clinical Data Interchange Standards Consortium. Trial Submission Studio is not affiliated with or endorsed by CDISC.

Regulatory Guidance

This software does not constitute regulatory advice. For guidance on:

• FDA submissions: Consult FDA Data Standards
• PMDA submissions: Consult PMDA guidelines
• EMA submissions: Consult EMA standards

Data Privacy

Trial Submission Studio:

• Processes all clinical data locally on your computer
• Does not collect usage analytics or telemetry
• Does not transmit clinical data over the network

Network communication is limited to user-initiated update checks via GitHub API. No clinical data or personal information is ever transmitted.

See our full Privacy Policy for details.

You are responsible for protecting any sensitive or confidential data processed with this software.

Reporting Issues

If you encounter problems:

1. Do not rely on potentially incorrect outputs
2. Report issues on GitHub
3. Validate outputs through independent means

Future Stability

We are actively working toward a stable release. Progress can be tracked on our Roadmap.

Questions?

• FAQ
• GitHub Discussions