Vault provides the ability to capture and manage different types of Issues across a study country or study site including Observations, Protocol Deviations, Mitigation Actions, and any other custom object types relevant to your business model. You can track Issues for follow up, promote or demote them to different object types, and seed them directly into Monitoring Events.
This functionality is available in all CTMS Vaults but requires some configuration by your Admin for full utilization.
Note: Depending on the configuration of your Vault, the Issue object may be labeled Protocol Deviation.
Creating Issues
You can create Issues from the related object sections of Study Site and Study Country records, from the Actions menu of the Study Quality widget on the CRA Homepage, from Admin > Business Admin, or from a custom tab.
Depending on the configuration of your Vault, you may also be able to create Issue records directly in a Monitoring Event when you are answering questions that require you to log follow up items.
Promoting & Demoting Issues
When configured, you can promote and demote individual Issue records to different Issue types. For example, you log an Observation type of Issue, but after review, you realize that it is actually a protocol deviation and requires escalation. In this case, you can change the object type to Protocol Deviation.
To change the object type of an Issue record:
- Navigate to an Issue record.
- From the Actions menu, select the appropriate option to promote or demote the Issue to a different issue type.
- In the Change Issue Type dialog, click Continue to confirm the change. Note that Vault will not store the values of any fields that do not exist on the new Issue type.
Copying Issues to Multiple Subjects
In configured Vaults, you can create identical Issue records for multiple Subjects at the same Site by selecting the Bulk Copy Issue action. Admin must configure the Bulk Copy Issue user action on the Issue object.
To bulk copy Issue records:
- Navigate to an Issue record.
- Select the Bulk Copy Issue user action. This opens a dialog.
- In the dialog, select the checkbox for all Subjects you want to create an Issue record for. The dialog only displays active Subjects at the Site listed on the Issue record.
- Click Continue.
Once you click Continue, Vault creates a new Issue record for each selected Subject identical to the original Issue record. Vault copies the original field values to the new Issue records and updates the Subject and Subject Group fields with the corresponding data for the new Subject. Vault also populates the Copied From field on new Issue records with the value of the original Issue record.
Related Permissions
You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner security profile.
If your Vault uses custom security profiles, your profile must grant the following permissions:
| Type | Pernission Label | Controls |
|---|---|---|
| Security Profile | Objects: Issue (pdv__ctms): Create, Edit |
Ability to create, edit, promote, and demote Issue records. Note that you must have Create and Edit permission on all object types for the Issue object. |
| Security Profile | Objects: Monitored Issue: Read | Ability to view the Monitored Issues that Vault seeds into a Monitoring Event record. |
| Security Profile | Objects: Monitored Issue: Create, Edit | Ability to create and edit Monitored Issue records. |
| Security Profile | Objects: Question: Read, Create, Edit | Ability to view, create, and edit Issues and follow up items on a Monitoring Event Question. |