The Proof of Concept Eligibility Synchronization Dashboard was added to manage Eligibility Mapping updates due to errors or protocol amendments. This allows to preserve existing Eligibility Mapping, which historically was lost when versioning the Eligibility Form. This dashboard component is study-specific. You will notice some similarities in the workflow with the Activity Plan versioning workflow.
The Eligibility Synchronization Dashboard is typically a Studies > Subject component Dashboard.
Pre-requisites:
A study is in active data collection with a defined Eligibility Base Form and Eligibility Mapping.
At least 1 Subject is already evaluated on the Study > Subject > Eligibility tab against the initial version of the Eligibility Criteria, i.e. the Eligibility Base Form is in Locked status.
Eligibility Synchronization dashboard is deployed.
Navigation:
To go to the Eligibility Synchronization Dashboard, go to Study > Subjects > Dashboard tab:
Filters
Eligibility Form Name and Status
Actions menu allowing to initiate the versioning and synchronization.
Subject selection tickboxes - user can select each individual Subject or use the top tickbox to select all Subjects.
Subject Information, including Subject Numbers, Current Eligbility Status, Cohorts.
Subject Eligibility Form Name - for easy identification of which Subjects are associated with which Eligibility Form and whether the Forms is outdated (synchronization icon).
Workflow:
1. Start Eligibility Form Versioning
Click Action > Version Form. You will be taken to the “Version Study Eligibility Form” screen:
On the “Version Study Eligibility Form” screen, define a new name for the Eligibility Form, ideally something that indicated the version of it. This is different to the usual Form Naming convention within ClinSpark, but it is important to have unique naming for the Eligibility Form versions. Provide a “Reason for Change” that will be used in the auditing of this action and click “Save”:
This action creates a new version of the Eligibility Form in an Unlocked state, renames it to your desired name, associates it with the Study Metadata, logs the appropriate audits and opens the new Eligibility Form for editing. This also unlocks the Eligibility Mapping and so, no new Eligibility evaluations will be possible against Subjects, until this versioning is done.
2. Update Eligibility Form
You can now edit the Eligibility Form by adding / removing Eligibility Criteria.
If the specific Eligibility Criterion that you are modifying is already in use for existing Eligibility Mapping, you will need to remove the mapping prior to being able to delete the Eligibility Criterion.
Once all the updates are made, Lock the Eligibility Form to confirm it is ready for use.
3. Update Eligibility Mapping
You can then adjust the Eligbility Mapping. All pre-existing mapping will be copied over for convenience. Add /remove mapping as required. Lock the Eligibility Mapping and document the “Reason for Change”.
4. Identify Subjects to Synchronize
You are now ready to review which Subjects will require synchronization. The Subjects who are not currently on the most recent version of the Eligibility Form will have the “synchronization” icon displayed in the “Subject Form” column.
The Filters will be useful here, as you might want to synchronize only certain Epochs, Cohorts or Subjects in specific Eligibility and overall Study Status.
You can select one/several/all Subjects using the checkboxes in the first column of the dashboard. Then click Action > Synchronize Subjects.
‼️ If the Subject Eligibility Form is not marked as Common, an error will appear. You will need to cancel out of this screen, go to CRF Design > Study Library Metadata page, click on the Subject Eligibility Form hyperlink, then Action > Edit, then ticket the “Common Form” tickbox, document the Reason for Change and save:
Then you can go back to synchronizing Subjects to the new Eligibility Form version.
5. Define the new Subject Eligibility Status, if applicable
When you initiate the synchronization of a new Subject Eligibility Form you will be able to select the new Eligibility Status for the Volunteer amongst the Eligibility Statuses in the “Unspecified” Category.
The options for the new Subject Eligibility Status after the update are configurable in Administration > General Settings > Data Collection > Eligibility Options. You can add new Eligibility Options in the “Unspecified” category:
These options will appear for selection, when synchronizing:
The PI may also filter against this Eligibility Status on the Study > Subjects page:
The Subjects who have the most recent Subject Eligibility Form will be excluded from the selection for synchronization:
The new Eligibility Criteria, Mapping and Subject Eligibility Status will be linked to the Subject Profile after a successful synchronization:
The old version of the Eligibility Base Form will appear as canceled.