Flywheel Core 21.3

21.3.0

FEATURES

Clinical Trial Imaging Workflow Management

Flywheel 21.3.0 introduces comprehensive imaging workflow management capabilities designed to support clinical trial operations. These capabilities enable organizations to manage imaging data collection, quality control, and reader assessments across both research and regulated environments. This release includes the new Tasks Manager module integrated with the V3 Viewer, providing a flexible foundation for clinical imaging workflows with deployment options for non-regulated and 21 CFR Part 11 compliant environments.

Core Deployment Configuration

The following capabilities are available for all Flywheel Core deployments and provide essential tools for managing imaging workflows across research environments, including academic studies, biomarker development, algorithm testing, and clinical trial operations:

Tasks Manager

A new task management system enables teams to create, assign, and track work assignments across imaging studies. Key capabilities include:

• Task Creation and Assignment: Create individual or bulk tasks and assign them to specific users or staffing pools for flexible resource allocation. Tasks support custom protocols with structured data collection forms rendered in the viewer.
• Staffing Pools: Organize users into pools based on roles, expertise, or availability. Assign tasks to pools rather than individuals, allowing any qualified pool member to complete the work. This improves workload distribution and reduces bottlenecks in reader studies and imaging assessments.
• Task Filtering and Management: Filter and sort tasks by assignee, creator, due date, priority, status, and other attributes. Track task progress through statuses including To Do, In Progress, and Completed.
• Protocol-Based Workflows: Associate tasks with versioned protocols that define structured data collection forms. Forms are rendered directly in the V3 Viewer during task execution, ensuring consistent data capture across all tasks using the same protocol.
• Task Reporting: Generate CSV reports containing task metadata, form responses, and links to annotation files for external analysis. Export options include form and annotation reports (one row per response) and project management reports (one row per task). Project management reports include task lifecycle information such as task status changes, assignee, creator, due dates, and completion timestamps for operational oversight and analysis.

V3 Viewer Integration

The V3 Viewer has been enhanced to support task execution workflows:

• Task Execution Interface: Open and complete tasks directly within the viewer. View task details, fill out protocol-defined forms, and submit responses without leaving the viewing environment.
• Form Rendering: Protocol forms are dynamically rendered in the viewer based on JSON schemas. Forms support various question types and validation rules to ensure complete and accurate data collection.
• Annotations Management: Create and save image annotations (measurements, segmentations) as part of task completion. Annotations are linked to specific tasks and can be reviewed alongside form responses in the task details view.
• Draft Saving: Save tasks as drafts to preserve partial work, including form responses and annotations, and resume later. Draft tasks retain all in-progress data until the assignee is ready to complete submission.
• Viewer Configuration: Customize viewer behavior at the project level for all tasks within that project, including display settings, measurement tools, and annotation label colors. Project-level configuration ensures consistent viewing environments across all tasks in the project.

Validated Deployment Configuration

For organizations operating under 21 CFR Part 11 compliance requirements, Flywheel Validated Instance deployments include all Core capabilities above plus additional compliance features:

Electronic Signatures

Task completion workflows integrate with Flywheel's electronic signature system:

• Task Submission with Electronic Signature: When completing a task, users verify their identity with multi-factor authentication (MFA) and provide a customizable reason code documenting the intent of their submission. The system cryptographically signs all submitted data including form responses and annotations, creating an immutable record that links the authenticated user identity, submission timestamp, reason code, and all collected data. This non-repudiable signature ensures that the task submission cannot be altered after completion.
• Signature Verification: View signature details including signer identity, timestamp, and signature reason in completed task records. All signature events are recorded in the audit trail for regulatory traceability and inspection.

Audit Trail Integration

Task and form response activities are logged in the Flywheel audit trail:

• Form Response Logging: Each form submission is logged with details of who submitted responses, when the submission occurred, and the protocol version used. Form field values are tracked individually in the audit record.
• Annotation Logging: Annotation creation and updates during task execution are logged to the audit trail with timestamps and user information. Annotation files are linked to specific tasks for complete traceability.
• Project Locking: When projects are locked for validation or audit activities, all associated tasks, form responses, and annotations become read-only. This prevents any modifications to collected data during compliance reviews.

Guided Case Uploader

A streamlined interface for clinical trial sites to upload imaging data with step-by-step guidance that ensures data quality and consistency across all contributors.

Clinical trial imaging data often has non-human-readable file names, making it difficult for site staff to confirm they are uploading the correct files. The Guided Case Uploader addresses this challenge by automatically inspecting DICOM headers to display patient identifiers, study descriptions, and series information, allowing contributors to verify they have selected the correct data before submission.

Key capabilities include:

• Pre-Defined Upload Paths: Session Template validation guides contributors to upload data to consistent container paths (Subject, Session, Acquisition) across all sites participating in the trial, ensuring organizational consistency and enabling trial coordinators to locate data reliably.
• Supplementary Metadata Collection: Form-based data entry captures information beyond what is contained in the imaging files, such as site-specific notes, quality assessments, or protocol compliance indicators.
• DICOM Data Verification: Automatic inspection of DICOM headers displays PatientID, StudyInstanceUID, and SeriesDescription to help contributors confirm they have selected the correct files. The system detects inconsistencies across selected files and provides review tools to identify and resolve discrepancies before submission.
• Automatic File Organization: DICOM files are automatically grouped by series and organized into ZIP files, while non-DICOM files (TIFF, PNG) are handled appropriately within the same workflow.
• Bulk Import Pipeline Integration: All uploads are processed through Flywheel's Bulk Import pipeline, which enforces quality and security checks including malware scanning and conflict detection, and provides monitoring and traceability tools for trial coordinators and data managers.

Data Transfer

• Design improvements to more clearly indicate why the Bulk Import and Bulk Export jobs list is not shown, whether that is because the jobs list is still loading, an error occurred while fetching the jobs list, or there are in fact no jobs to display.
• When a user uploads and imports files from "My Computer" via Bulk Import, the files that eventually get placed into Core show the "Creator" as the user who uploaded the files.

Viewers

V2 Viewer

• Performance optimization: added Cache-Control headers to V2 Viewer application bundle to reduce application load times.

V3 Viewer

• Added footer bar displaying instructions for the active tool.
• Improved error handling with descriptive error messages when the viewer configuration file is incorrect or when issues occur during viewer launch.
• Enhanced viewport synchronization: Zoom levels and pan can now be synchronized between viewports displaying the same dataset, even when the dataset is missing the ImageOrientationPatient DICOM tag.

Web App

Performance Improvements

• Faster page loads and navigation when accessing projects.
• Performance improvement to jobs log page loading by listing the most important data first.

FIXES

• Added a progress indicator for jobs log filtering.

Data views

• Resolve an issue with data views where adding the acquisition.label column to a view that already has the analysis.label column causes the view to return empty data.

Gears and Compute

• Resolved issue with FW compute that was causing long startup times for dynamic compute. This caused gear job startup times of 30 min in some cases.

Viewers

V2 Viewer

• Fixed indexing issues that could occur when rapidly creating multiple files in a single acquisition. This could happen when creating a Smart Copy of a project or during ingest of a large number of files.