Workflow steps:
Open-source trial-level workflow proceeds as follows:
- TrialOwner User creates ClinicalTrial and TrialArm
- TrialOwner specifies which patients are included in TrialArm
- TrialOwner creates Timepoints (e.g. Baseline, Follow-up) through the Study Association modal for various patients
- Optional: TrialOwner assign PatientIds / Timepoints to Review to Readers
- Reader chooses Timepoints to Review based on Study Worklist, Timepoint Worklist, or the Reader's assigned work (new page?)
- Reader loads LesionTracker with specified Timepoints and creates / updates Measurements
- Measurements are saved as created/updated by Reader, Timepoint is marked as Reviewed in the TrialArm Model
In Precision Imaging Metrics approach, LesionTracker usage starts at Step 6.
Model types (from highest in hierarchy to lowest):
- User
- ClinicalTrial
- TrialArm
- Timepoint
- Study
- Measurement
Descriptions & notes
User
- Users can have various privileges depending on their status: Reader, TrialOwner, Administrator, for example
- Readers can only create and edit measurements
- TrialOwners can create and manage trials, trial arms, and associate studies with timepoints
- Administrators can create/manage/delete all data models, including other Users
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- Trial arms can include one or more timepoints
- Trial arms store whether or not a timepoint has been reviewed already
Timepoint
- Timepoints contain one or more studies
- Timepoints can be part of multiple trial arms and trials
- Created manually by a trial owner
- When a single Study is selected, the system suggests the inclusion of other Studies with the same StudyDate and PatientId
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