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The dashboard component allows Eligibility Mapping updates to be managegmanaged, perhaps which may be necessary due to protocol amendment or scenarios where corrections are needed after the initial Eligibility Form has been put into useused. The features allow it to preserve existing Eligibility Mapping, which historically was lost when versioning the Eligibility Form.
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Eligibility Synchronization dashboard is deployed.
Navigation
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To go to the Eligibility Synchronization Dashboard, go to Study > Subjects > Dashboard tab:
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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Name - for easy identification of which Subjects are associated with which Eligibility Form and whether the Forms is outdated (synchronization icon).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
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1. Start Eligibility Form Versioning
Click Action > Version Form. You will be taken to the “Version Study Eligibility Form” screen:
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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.
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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.
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