Data Processing Workflow
The workflow in SliceVault can be tailored to each study protocol. Depending on your study’s requirements, you might have only a single Submission step or include multiple QC stages and Central Reading. User access to data and functionality is governed by the chosen workflow configuration. Below are several common workflow examples.
Example 1: Store and Hold
- Submission
In this simplest scenario, data is uploaded by the investigator and stored without any subsequent steps. SliceVault merely holds the data until further action (for example, exporting or archiving).
Example 2: Submission → QC
- Submission
- QC Review
During the Submission step, the Investigator uploads images and related data before submitting the visit. Once submitted, the QC Manager gains access to that visit, completes the QC checklist, and either approves—finalizing the visit’s status—or rejects it, sending it back to the Investigator for correction.
Example 3: Submission → QC → Central Reading
- Submission
- QC Review
- Central Reading
During the Submission step, the Investigator uploads and submits the visit. The QC Manager then reviews the data; if approved, the visit advances to Central Reading, but if rejected, it is sent back to the Investigator.
In Central Reading, one or more Readers assess the visit. A single Reader may review and either approve or reject, whereas studies with multiple Readers in parallel have each Reader perform an independent assessment, with consensus rules determining the outcome. If Readers disagree, an adjudicator can resolve any discrepancies. Studies may also be conducted in a reader-blind mode, where Readers do not see certain patient and visit information, or in an open-reading mode, where Readers see all information.
Example 4: Submission → QC 1 → QC 2 → Central Reading
- Submission
- QC 1 Review
- QC 2 Review
- Central Reading
During the Submission step, the Investigator submits the visit. QC 1 then performs the first-level quality check; if approved, the visit advances to QC 2, but if rejected, it returns to the Investigator for corrections. QC 2 conducts the second-level quality check—approval moves the visit forward, while rejection sends it back to the Investigator.
In Central Reading, one or more Readers perform the final assessment. Studies may use a single Reader, parallel Readers, or Readers with adjudication; in a reader-blind setup, Readers do not see certain patient and visit information, whereas in an open-reading setup, Readers see all information.
Visit Status
The visit status is used to move images between workflow steps. SliceVault operates with the following visit statuses:
| Status Code | Status Name | Description |
|---|---|---|
| 0 | Submission Pending | Images have been uploaded, but the visit has not yet been submitted to QC. |
| 1 | Pending QC 1 | The visit has been submitted to QC 1 and is available to the QC 1 user. |
| 2 | Rejected by QC 1 | QC 1 has rejected the visit, returning it to the Investigator for corrections. |
| 3 | Approved by QC 1 | QC 1 has approved the visit—if QC 2 exists, it advances to QC 2; otherwise, it proceeds to Reader. |
| 4 | Rejected by QC 2 | QC 2 has rejected the visit, returning it to the Investigator for corrections. |
| 5 | Approved by QC 2 | QC 2 has approved the visit, advancing it to the Reader. |
| 6 | Pending Reader | The visit is available for Reader assessment. |
| 7 | Approved by Reader | The Reader has approved the visit, marking it as reviewed. |
| 8 | Rejected by Reader | The Reader has rejected the visit, returning it for further QC or Investigator action. |
| 9 | Completed by Reader | The Reader has completed their assessment and finalized the visit. |
Access Restrictions
Project users’ access to data and functionality depends on the workflow configuration and their user role. Data becomes available to a given user only when the visit reaches the status assigned to that role. For example, a submitted visit is available to the first QC Manager only after the Investigator has submitted the data, and not before.