You can manage your Study, Study Country, and Study Site records with an object lifecycle. When you manage TMF objects with lifecycles, you’ll need to configure lifecycle state user actions for users to change records’ states. You can also configure workflows for your Study Site records to auto-fill fields with the parent record’s values.
How to Enable Lifecycles for TMF Objects
From Admin > Settings > Application Settings, select the Enable Lifecycle for Study, Study Country, and Site checkbox. After you click Save, the enablement process may take a minute.
Once you enable this feature, you cannot disable it. You also cannot stop using the standard lifecycles on your TMF objects without deleting all object records and related object workflows. Carefully plan prior to enabling this feature and check that this won’t break any of your integrations.
We recommend removing the Status (status__v) and Site Status (site_status__v) object fields from the object page layout to avoid confusion with the status as lifecycle state.
Standard Lifecycles for TMF Objects
Enabling lifecycles for TMF objects provisions standard lifecycles. You cannot associate TMF objects with custom lifecycles, but you can make configuration changes to the standard lifecycles as needed.
- Study Lifecycle
- Study Country Lifecycle
- Site Lifecycle
The standard lifecycle states correspond to the Status field on your TMF objects. When using lifecycles, changing the Status of a study object no longer cascades changes to country and site records. You must initiate a user action on each record to change its state.
When you create a new state or edit an existing state in one of these three lifecycles, choose a Status to associate with the state from the Set Record Status to picklist.
Archiving Study Records with Lifecycles
You can configure your Vault so that users with the appropriate access can archive a study. When configured, Vault moves all study documents into the Vault archive and moves the study, its countries, and its sites to the Archived lifecycle state. Archiving a study will also move EDLs and certain study-related records to Inactive status.
Licensing Enforcement
The number of sites for licensing purposes includes all sites in states not associated with the Inactive lifecycle state. The number of inactive sites includes only sites in the Inactive state.