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.
Overview
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 .