EORTC Data Submission

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Overview

This guide walks through submitting clinical trial data with AitriumOS for EORTC trials, which use a per-patient dataset checklist. 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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Adding a Patient

Before you can submit data for a patient, the patient must be added to the trial:

1. Open the trial in AitriumOS and select Add Patient.
2. Enter the patient’s Trial Patient ID exactly as assigned by the trial.
3. The patient appears in the Submit a Patient Dataset table, ready for submission.

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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 dataset against a clinical trial’s specific dataset file 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.

This step will run automatically and only require action if there is a failure.

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4. Final Review

Before submission, the user can:

• Review dataset completeness.
• Approve data for submission.

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5. Upload to Trial

The final step packages the approved dataset as a zip file named according to the clinical trial requirements, then completes the submission in two parts:

1. Data Transfer — the dataset is uploaded to the trial’s data destination, with a progress bar tracking the transfer.
2. Aitrium Sync — the submission is registered with Aitrium, which records it for the trial and notifies the trial team.

Both parts run automatically, and the transfer progress card shows which one is underway. When both finish, AitriumOS shows the Submission complete screen. While the upload is in progress, keep AitriumOS open. The Submission complete screen. A progress bar at 100% is not this screen — the submission is still finishing.

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Monitoring Submission Status

Verifying the submission is the final step of every upload — don’t skip it:

1. Navigate to the trial homepage in AitriumOS.
2. Find the patient in the Submit a Patient Dataset table and confirm the submission registered: the patient’s Last Sent time reflects your upload, and the dataset’s status no longer shows Submit Dataset.

If the Last Sent time has not updated after you saw the Submission complete screen, the submission did not finish registering — see Troubleshooting.

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Resubmitting a Dataset

A submission may need to be repeated — for example, when a dataset was incomplete, an upload failed partway through, or the trial team requests a corrected dataset.

1. Navigate to the trial homepage in AitriumOS and locate the patient in the Submit a Patient Dataset table.
2. The dataset’s action button reflects what is needed:
   • Complete Required Items — the dataset is missing required items; provide them to finish the original submission.
   • Resubmit Dataset — the dataset should be submitted again; selecting it restarts the submission flow for that patient.
3. Prepare the corrected dataset and proceed through the same validation, standardization, de-identification, and review steps as the original submission.

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Best Practices

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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
• Confirm your institution’s firewall permits the outbound transfer connection — see Before You Begin
• Check available disk space
• Ensure you have proper trial permissions
• Contact support if issues persist

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Upload finished but the dataset doesn’t show as submitted

If the upload completed but the patient’s row on the trial page doesn’t reflect it — the Last Sent time has not updated, or the dataset still shows Submit Dataset — the application was most likely closed before the submission finished registering. The trial team received the files, but no notification was sent and the submission was not recorded. To resolve:

• Run the submission again for that patient from the Submit a Patient Dataset table, exactly as you did the first time. The trial team can disregard the duplicate file.
• If the dataset still does not show as submitted, contact [email protected] with your trial ID and patient ID.

Verifying every submission on the trial page right after uploading (see Monitoring Submission Status) catches this immediately instead of weeks later.

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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]