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.
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.
Adding Issues to Monitoring Events
If configured, Vault relates Issues and Monitoring Events by creating simple join Monitoring Event records. You can manually connect Issues with Monitoring Events, and Vault can automatically seed Issues that fit specific criteria to a Monitoring Event.
Manually Add Issues
Depending on the configuration of your Vault, you can manually add Issues to Monitoring Events in several ways:
- Select a value in the Monitoring Event field on the Issue record
- Add Issues to the related object section of a Monitoring Event record
Vault will not remove any Issues that you manually add to a Monitoring Event, even if they no longer fit the criteria that would cause them to be automatically seeded. See details below.
Depending on the configuration of your Vault, Vault can seed relevant Issues into Monitoring Event records in several ways:
- Automatically when a Monitoring Event reaches a specific lifecycle state
- Via manual user action on the Monitoring Event record
To manually seed related Issues to a Monitoring Event, navigate to a Monitoring Event, and select the option to seed Issues from the Actions menu.
When initiated, Vault populates the related object section of the Monitoring Event record with all unresolved issues that have the same Study Site value as the Monitoring Event. Vault will also add resolved issues if the Resolved Date of the Issue meets one of the following criteria:
- After the Actual Visit End Date of the previous Monitoring Event and on or before the Actual Visit End Date of the current Monitoring Event
- After the Actual Visit End Date of the previous Monitoring Event and on or before the current date
- On or before the current date or the current Actual Visit End Date of the current Monitoring Event
Each subsequent time you execute the action, either by moving the Monitoring Event record to a specific lifecycle state or manually executing the user action, Vault removes the Issue that no longer meet the criteria described above. However, Vault will not remove any Issue you manually added to the Monitoring Event nor will it re-seed any Issue you manually removed from the Monitoring Event.
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:
|Security Profile||Objects: Issue
||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.|