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Overview

This guide walks through the submission protocol for required clinical trial data using AitriumOS. The submission process ensures your data meets all trial requirements while maintaining patient privacy through standardization and de-identification.

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Step-by-Step Walkthrough

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Submission Process

The clinical trial data submission protocol consists of five key steps:

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1. Trial Dataset Validation

The first step validates your patient data against a clinical trial’s specific requirements:
  • Verifies presence of required patient data files
  • Identifies missing or invalid data elements
  • Validates DICOM headers against a trial’s requirements
  • Provides detailed feedback for any validation issues

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2. Structure Standardization

For trials requiring RT Structure Set file submission, this step:
  • Labels organ and target volumes according to the trial specific nomenclature
  • Maps local naming conventions to the trial specific nomenclature
  • Ensures adherence to trial-specific structure requirements

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3. DICOM Metadata Validation & De-identification

This critical step protects patient privacy by:
  • Analyzing all DICOM headers for potentially identifying information.
  • Applying the clinical trial’s de-identification policy to the DICOM file metadata.

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4. Final Review

Before submission, the user can:
  • Verify and amend the applied trial specific structure names
  • Confirm de-identification completeness
  • Review validation results
  • Approve data for submission

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5. Upload to Trial

The final step sends:
  • A zip file for the patient dataset named according to the clinical trial requirements.
  • Provides upload progress tracking
  • Confirms successful submission

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Monitoring Submission Status

After submission, you can track the status of each patient dataset:
  1. Navigate to the trial homepage in AitriumOS
  2. View dataset completion status for each Trial Patient ID.

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Best Practices

  • Ensure that all supplementary non-DICOM files have been pseudonymized.
  • Ensure that DICOM images do not have burned-in pixels with personally-identifiable information.
  • Ensure all trial required DICOM data is available for submission
  • Review the completeness status and address data omissions or errors before proceeding.

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Troubleshooting Common Issues

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Validation Failures

If dataset validation fails:
  • Check the Analysis Result’s Data Errors tab. The DICOM data provided may be corrupted.
  • Check that all trial specific required DICOM data and series are present in the selected folder for upload

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Structure Standardization Issues

For RT structure problems:
  • Confirm RTSTRUCT files are properly linked to image series
  • Check that structure names can be mapped to trial standards
  • Review the standardization mapping table

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Upload Errors

If uploads fail:
  • Verify your internet connection stability
  • Check available disk space
  • Ensure you have proper trial permissions
  • Contact support if issues persist

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Trials Module Deep-Dive

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Need Help?

If you encounter any issues during the submission process:
  • Review the error messages carefully
  • Consult the trial-specific requirements documentation
  • Contact support at [email protected]
  • Include your trial ID and patient ID when reporting issues