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Advanced Trial Configuration

Once a protocol-driven trial is live, you have a suite of configuration tools to refine the setup. These features let you tailor arms/regimens, enforce dose constraints, shape the data collection timeline, and set up site-events for ongoing quality and compliance.

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1. Manually Create or Edit Study Arms & Regimens

You can fine-tune the treatment structure of your trial beyond automatic extraction:
  • Use the Arms & Regimens editor to add new arms (e.g., “Adaptive”, “Hypofractionated”) or deactivate existing ones
  • Define each regimen’s dose, fractionation, and modality (e.g., 60 Gy in 30 fx, IMRT)
  • Reassign patients to updated arms when needed
  • All changes are logged and version-controlled

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Key Features

  • Add unlimited study arms to accommodate trial complexity
  • Configure treatment parameters specific to each arm
  • Maintain audit trail of all modifications
  • Update active trials without disrupting ongoing data collection

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2. Add Dose Constraints to Treatment Regimens

Each regimen can have one or more ROI-specific dose constraints:

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Example Constraints

  • Spinal Cord: Dmax < 45 Gy
  • Heart: V20Gy < 10%
  • Lung: Mean < 12 Gy

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Constraint Types

  • Hard constraints: Must-pass requirements that block submission if violated
  • Soft constraints: Advisory warnings that flag potential issues
Constraints are used in QA review and scorecard generation to ensure protocol compliance across all participating sites.

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3. Advanced Data Collection Schedules

The schedule of expected data submissions can be customized beyond the protocol-extracted defaults:

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Customization Options

  • Add/edit events such as “Week 3 Mid-Tx” or “Follow-up Month 6”
  • Specify required file types (e.g., CT, RTSTRUCT, MRI, RTDOSE)
  • Configure timing logic (e.g., every 3 months, ±5 days)
  • Apply globally or to specific arms for arm-specific data requirements

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Event Types

  • Patient-level events: Tied to individual patient timelines (treatment start, follow-ups)
  • Site-level events: Apply to the entire site (training, credentialing, audits)

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4. Configure Site-Level Events

To enforce standards and facilitate site onboarding:

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Site-Level Events

Configure critical milestones for each participating site:
  • Investigator training windows: Schedule and track required training sessions
  • Credentialing deadlines: Ensure sites meet qualification requirements
  • Interim QA audits: Schedule periodic quality assessments
These events appear on the trial dashboard for each site, providing visibility into trial readiness and ongoing compliance.

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Best Practices

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Version Control

  • Always review draft versions before publishing. Onced published, the changes to your protocol will automatically take affect.
  • Review the version history to track trial evolution

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Testing

  • Test data collection schedules with sample submissions
  • Verify dose constraints with representative treatment plans