Lesion Tracker Data Model Design

Workflow steps:

1. TrialOwner User creates ClinicalTrial and TrialArm
2. TrialOwner specifies which patients are included in TrialArm
3. TrialOwner creates Timepoints (e.g. Baseline, Follow-up) through the Study Association modal for various patients
4. Optional: TrialOwner assign PatientIds / Timepoints to Review to Readers
5. Reader chooses Timepoints to Review based on Study Worklist, Timepoint Worklist, or the Reader's assigned work (new page?)
6. Reader loads LesionTracker with specified Timepoints and creates / updates Measurements
7. Measurements are saved as created/updated by Reader, Timepoint is marked as Reviewed in the TrialArm Model

Model types (from highest in hierarchy to lowest):

1. User
2. ClinicalTrial
3. TrialArm
4. Timepoint
5. Study
6. 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

ClinicalTrial

• Trials can be created and managed by a TrialOwner
• Trials contain one or more trial arms

TrialArm

• 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

Study

• Represents a single DICOM study at a specific study date
• Relates to a single patient by PatientId

Measurement

• Created by a User
• Updated by a User
• Related to a Study, Timepoint, Trial Arm, and Trial
• Future: Sets of Measurements can be cloned between TrialArms