Learn how to update your Vault’s configuration to enable Regulatory Agencies as Standard Organizations.
About the Feature
Worldwide regulatory agencies were added as standard Organization records in 20R3.
Configuration for Legacy Vaults
Vaults created in 20R3 or later include the following user action by default, while Admins must configure this action on Vaults created in 20R2 or earlier.
Add User Action to the Organization Lifecycle Inactive State
- In Admin, go to Configuration > Object Lifecycles > Organization Lifecycle > Inactive.
- Select Edit from the User Actions section.
- Select Create Rule.
- Create the User Action with the following configuration:
- Always
- Change State To
- Active
- Action Label: Change State to Active
- Select Save.
Configuration for All Vaults
You will have to add the following user action to all Vaults.
Add User Action to the Transmission Profile Lifecycle Inactive State
- In Admin, go to Configuration > Object Lifecycles > Transmission Profile Lifecycle > Inactive.
- Select Edit from the User Actions section.
- Select Create Rule.
- Create the User Action with the following configuration:
- Always
- Change State To
- Active
- Action Label: Change State to Active
- Select Save.
Activate the Organization and Transmission Profile
By default, worldwide regulatory agency organizations are provisioned as Inactive in all Vaults.
If you must submit to an agency, perform the following steps:
- Change the state of the Agency Organization record to Active.
- Change the state of the associated Transmission Profile to Active, or add a new Transmission Profile as needed.
Next Steps
- Verify the agency is Assigned Jurisdictions over the correct countries
- Verify that your Vault has the appropriate Product and Study Registrations
- Assign a Reporting Rule Set to the agency.
- Configure a Gateway for electronic submissions to the agency.