In addition to standard roles used in Data Central (Read Only, Data Manager, Medical Data Reviewer, Medical Coder, Site Monitor, Medical Monitor, and Pharmacovigilance), custom roles can be created and configured at the URL level. After custom role(s) have been added at the URL level, those roles can be assigned when configuring the Reviewer Roles for a study. Custom roles can be given the same access as the standard roles used in Data Central, such as marking data as reviewed in Data Review, raising Issues in Data Review and Graphical Patient Profiles (if enabled), and for assigning Issues to the role and receiving role notifications. If query processing is configured, custom roles can also optionally issue and process queries.
Custom roles can be included in an export when replicating configurations across URLs. A checkbox labeled ‘Roles’ is available in the System area of the Export System Configuration window. When this checkbox is checked, the Data Central role names and abbreviations are included in the export.
Add a New Custom Role
- Click the 9-dot icon to open the Platform Menu.
- Select Configuration under Platform Configuration on the left side of the menu. The Configuration window opens.
- From the left navigation, select Roles.
- Standard and custom roles are listed showing the role name and abbreviation. Within Roles, new roles can be added and edited by using the icons in the master header.
- Standard roles are shown on the listing but are not editable, whereas custom roles are editable and can be deleted by a user with System Configure privileges if they are not being used by any study in the URL.
- Click the plus sign in the master header. The Add Data Central Role window opens.
- Enter a unique Name.
- Enter a unique Abbreviation.
- Click Save. The custom role is added to the list in alphabetical order.
Important: Attempting to add a role with an existing abbreviation will result in an error message that the abbreviation is already in use and the user will be prevented from adding the custom role. Attempting to delete a role that is in use will result in an error message that the role is in use and the deletion will be denied.
Edit a Custom Role
- From the Configuration window, select Roles in the left navigation.
- Click the row of the custom role to edit. The row highlights in blue.
- Click the Edit icon in the master header.
- Update the Name and Abbreviation as needed.
- Click Save.
Delete a Custom Role
- From the Configuration window, select Roles in the left navigation.
- Click the row of the custom role to delete. The row highlights in blue.
- Click the Delete icon in the master header. A confirmation dialogue displays.
- Click Yes to confirm deletion, or click No to cancel.