Your CTMS Vault provides the ability to capture and manage multiple types of Issues across a study country or study site including Observations, Protocol Deviations, Mitigation Actions, and any other custom object types. Users can track Issues for follow up, promote or demote them to different object types, and seed them directly into Monitoring Events.
Note: As of 21R1, we recommend that you update the label on the Protocol Deviation (
pdv__ctms) object to Issue in all CTMS Vaults.
To fully utilize issue management functionality, we recommend that you perform the following configuration tasks in your Vault:
- Activate all relevant Issue object types. Note that only active object types are displayed on the Quality widget on the CRA Homepage.
- Create a page layout for the Observation object type of the Issue object.
- Configure the Change Issue Type user action on the relevant states of the Issues lifecycle so that users can promote and demote Issues.
- Update permission sets to grant users access to Issue objects.
- Optional: Configure the Monitoring Event object and lifecycle to allow Issues to be seeded directly into related Monitoring Event records.