Troubleshooting

Common issues and their solutions when using Trial Submission Studio.

Import Issues

File Won’t Import

Data Appears Garbled

Cause: Encoding mismatch

Solution:

1. Open the file in a text editor
2. Save with UTF-8 encoding
3. Re-import

Missing Columns

Cause: Header row issues

Solution:

1. Verify first row contains headers
2. Check for BOM (byte order mark) issues
3. Remove hidden characters

Mapping Issues

No Suggested Mappings

Cause: Column names don’t match SDTM variables

Solution:

1. Manually map columns
2. Consider renaming source columns
3. Create a mapping template for reuse

Wrong Automatic Mappings

Cause: Fuzzy matching misidentified variables

Solution:

1. Review all automatic mappings
2. Manually correct incorrect mappings
3. Adjust match confidence threshold in settings

Can’t Map Required Variable

Cause: Source data missing required information

Solution:

1. Add the missing data to source file
2. Derive from other columns if possible
3. Consult with data manager

Validation Issues

Too Many Errors

Cause: Data quality issues or incorrect mappings

Solution:

1. Address errors in priority order
2. Fix mapping issues first
3. Clean source data if needed
4. Re-validate after each fix

Controlled Terminology Errors

Cause: Values don’t match CDISC CT

Solution:

1. Review expected values in the error message
2. Map source values to standard terms
3. Update source data if appropriate

Date Format Errors

Cause: Non-ISO date formats

Solution:

1. Convert dates to ISO 8601 format (YYYY-MM-DD)
2. Or use partial dates where appropriate (YYYY-MM, YYYY)

Export Issues

Export Fails

Truncated Data in XPT

Cause: Values exceed XPT limits

Solution:

1. XPT V5: Max 200 chars per variable
2. Check variable lengths before export
3. Consider using XPT V8 for longer values

Missing Variables in Output

Cause: Variables not mapped or derived

Solution:

1. Verify all required mappings
2. Check if derived variables were created
3. Review export settings

Performance Issues

Slow Import

Cause: Large file size

Solution:

1. Allow time for large files
2. Consider splitting into smaller files
3. Close other applications
4. Increase available RAM

Application Freezes

Cause: Processing large datasets

Solution:

1. Wait for operation to complete
2. Check progress indicator
3. If unresponsive after 5+ minutes, restart
4. Process smaller datasets

High Memory Usage

Cause: Large dataset in memory

Solution:

1. Close unused files
2. Process one domain at a time
3. Restart application to free memory

Application Issues

Application Won’t Start

macOS:

# If blocked by Gatekeeper
xattr -d com.apple.quarantine /Applications/Trial\ Submission\ Studio.app

Linux:

# Ensure executable permission
chmod +x trial-submission-studio

Windows:

• Run as administrator
• Check antivirus isn’t blocking

Crashes on Startup

Solution:

1. Delete configuration files:
   • macOS: ~/Library/Application Support/trial-submission-studio/
   • Windows: %APPDATA%\trial-submission-studio\
   • Linux: ~/.config/trial-submission-studio/
2. Reinstall the application

Settings Not Saved

Cause: Permission issues

Solution:

1. Ensure write access to config directory
2. Run application with appropriate permissions

Getting Help

Collect Information

Before reporting an issue, gather:

1. Application version (Help → About)
2. Operating system and version
3. Steps to reproduce
4. Error messages (screenshots)
5. Sample data (anonymized)

Report an Issue

1. Check existing issues
2. Create a new issue
3. Include collected information

Community Support

• GitHub Discussions

Quick Reference

Keyboard Shortcuts for Recovery

Log Files

Application logs are located at:

• macOS: ~/Library/Logs/trial-submission-studio/
• Windows: %LOCALAPPDATA%\trial-submission-studio\logs\
• Linux: ~/.local/share/trial-submission-studio/logs/

Include relevant log excerpts when reporting issues.