Privacy Policy
Trial Submission Studio is designed with privacy as a core principle.
Data Collection
We do not collect any data. Trial Submission Studio:
- Does not collect usage analytics or telemetry
- Does not track user behavior
- Does not collect personal information
- Does not access or transmit clinical trial data
Local Processing
All clinical data processing occurs entirely on your local computer:
- Source files (CSV, XPT) are read locally
- Transformations execute in local memory
- Output files are written to local storage
- No data is uploaded to any server
Network Communication
Trial Submission Studio connects to the internet only when you explicitly request it:
| Action | Destination | Purpose |
|---|---|---|
| Check for Updates | api.github.com | Fetch latest release info |
| Download Update | github.com | Download new version |
Important:
- Update checks are user-initiated only (not automatic)
- No clinical data is ever transmitted
- No personal information is sent
- All connections use TLS encryption
This complies with SignPath Foundation’s requirement:
“This program will not transfer any information to other networked systems unless specifically requested by the user.”
Third-Party Services
The only third-party service used is GitHub for:
- Hosting releases and source code
- Providing update information via GitHub Releases API
For GitHub’s data practices, see: GitHub Privacy Statement
Data Storage
Trial Submission Studio may store the following locally:
| Data | Location | Purpose |
|---|---|---|
| User preferences | OS config directory | Remember settings |
| Recent files list | OS config directory | Quick access |
| Window state | OS config directory | Restore layout |
Storage locations by platform:
- Windows:
%APPDATA%\trial-submission-studio\ - macOS:
~/Library/Application Support/trial-submission-studio/ - Linux:
~/.config/trial-submission-studio/
No clinical data is ever stored by the application itself.
Your Responsibilities
You are responsible for:
- Protecting clinical data on your system
- Compliance with HIPAA, GxP, 21 CFR Part 11 as applicable
- Secure storage of source and output files
- Access control on your computer
Changes to This Policy
Changes will be documented in release notes and this file.
Contact
Questions about privacy: GitHub Discussions