Privilege Definitions
Access to elluminate modules and studies, as well as the ability to perform specific actions, will require the appropriate privileges.
| PRIVILEGE | APPLIES TO | DEFINITION |
|---|---|---|
| Administer | System | This privilege provides the user access to all system, module, and study functionality, as well as user configuration. |
| Analytics | Studies, Global Data Stores, Compounds, Programs, Therapeutic Areas, and Apps | This privilege allows the user to access specific apps (using the Apps accordion) within Analytics and view any published sheets (public and community) contained within those apps. It also enables users to create Bookmarks and Stories, while restricting them from making any modifications to visualizations, such as adding or altering sheets. The Apps accordion displays all apps deployed to the URL, allowing administrators to specify which apps a user or user group can access. |
| Analytics Customize | System | This privilege provides the user with the ability to create a new data model for Analytics or to make modifications to a current data model, such as CDA. |
| Analytics Edit | System | This privilege provides the user with the ability to create, modify and publish sheets within the visualizations. A user must have the 'Analytics' privilege to access the visualizations. |
| Blinded Data Configure | Studies | This privilege allows the user to configure a study for Unblinding / Blinding. This privilege only permits configuring blinded data and does not grant the ability to view blinded data. |
| Blinded Data View | Studies | This privilege allows a user to view blinded data. By default, users cannot see or access blinded data. This privilege can only be assigned at the User level and cannot be added to a Group. |
| Data Central | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege allows the user to access Data Central. The actions a user can take within Data Central are configured within Data Central Configuration and based on the assigned reviewer role. |
| Data Central Designer | System | This privilege allows the Data Central user to save and manage public Workspaces, public Visualizations, and public Filter Sets within a defined folder structure and configure the security. It also allows the user to create and manage Patient Profiles, as well as configure and manage Advanced Filters and Data Cuts. |
| Data Quality | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with the ability to complete validations within the Data Quality module. |
| Delete Study | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with the ability to delete a study. |
| eDrive Global Read | System | This privilege provides the user with access to the root folder in eDrive. This allows access to any folder outside of the study. The user would still need the 'eDrive Read' privilege to access study folders. |
| eDrive Global Read Write | System | This privilege provides the user with Read / Write access to the root folder in eDrive. This allows access to any folder outside of the study. The user would still need the 'eDrive Read' privilege to access study folders. |
| eDrive Read | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with Read access to the study folder(s) and all subfolder(s) of the selected study. |
| eDrive Read Write | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with Read / Write access to the study folder(s) and all subfolder(s) of the selected study. |
| eForms | System | This privilege provides the user with access to eForms, allowing them to view, enter, edit, and delete any data entered into an eForm. |
| eIQ Review | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides access to eIQ Review in Data Central. |
| Exporter | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with access to the Exporter module within a study, allowing them to export data from elluminate into the following formats: Excel, CSV, Delimited tilde, or Delimited vertical bar. The 'SAS Exporter' privilege is also required to Export in SAS formats. |
| Global Library Configure | System | This privilege allows the user to manage the Global Library used in Mapper. |
| Global PDAP Configure | System | This privilege allows the user to access the Protocol Deviation Assessment Plan (PDAP) under the Metadata Management section of the platform menu and the ability to configure the Global PDAP. |
| Importer | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with access to the Importer module within a study, allowing them to import data into elluminate. The user can also run an existing import definition or a manual import. |
| Issue Administration | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege allows the user to edit Issue Text and the Due By date in the Edit Issue window within Issues and Data Central. This privilege also allows the user to upload an Excel file containing a list of open issues that have been addressed within the uploaded file. |
| Manage Users | System | This privilege provides the user with access to User Management for the purpose of administering user information and access to elluminate. |
| Mapper | System | This privilege provides the user with access to Mapper for building transformations. |
| Mapper Advanced | System | This privilege provides the ability to create Dynamic Mapping Templates. |
| Metadata Editor | System | This privilege provides the user with the ability to edit the available metadata for a study and to remove domains. |
| ODR Analytics | System | This privilege allows read-only access to the Operational Data Repository (the module) and access to the Operational Oversight app within Analytics. |
| ODR Configure | System | This privilege allows the user to configure picklists and fields within the form details and listings of the Operational Data Repository, but no access to the Analytics Operational Oversight app. |
| ODR Read | System | This privilege allows read-only access to the Operational Data Repository. |
| ODR Read Write | System | This privilege allows read and write access to the Operational Data Repository (the module), but no access to the Analytics Operational Oversight app. |
| Patient Profile Configure | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege allows users (without the 'Data Central Designer' privilege) to create and manage patient profiles. |
| Patient Profile View | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege is no longer needed for new users; however, legacy users will continue to see this as a separate privilege. Users with the Data Central privilege can view the Graphical Patient Profile within Data Central as it was configured. |
| Protocol Deviation Edit | Studies | This privilege provides the user with access to the study Protocol Deviations (PDs) Dashboard and allows them to manually add PDs or edit existing PDs. |
| Protocol Deviation View | Studies | This privilege provides the user a read-only view of the Protocol Deviations Dashboard. |
| RACT Assessment Read Only | Studies, Compounds, Programs, and Therapeutic Areas | This privilege provides the user read-only access for users to view data in the RACT module. |
| RACT Assessment Read Write | Studies, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with access to the RACT module, and the ability to conduct assessments. |
| Read Only User | System | This privilege provides the user with read-only access to the elluminate platform for comprehensive visibility of audit events across all users and actions in the URL. |
| RBQM | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with access to the Risk Based Quality Management (RBQM) module in Data Central. |
| Reporting DB | System | This privilege provides the user with access to the Reporting Database for studies configured for the Reporting Database. Each user with this privilege must also have a Reporting Database username and password. |
| Risk Management Configuration | System | This privilege provides the user with access to Configuration within Risk Management, allowing for the configuration of RACT, and global-level RBQM items. It also includes existing access from both the 'RACT Assessment Read Write' and 'RBQM' privileges. |
| Run Reports | System | This privilege provides the user with access to the Reports module, allowing them to run administrative reports. |
| SAS Exporter | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with access to export SAS-specific formats like XPT or sas7bdat. This privilege requires the 'Exporter' privilege, and allows the user to select the option to export in SAS and SAS XPORT formats. |
| SCE | System | This privilege provides the user with access to the SCE module and the ability to navigate to SCE components. |
| SCE Configure | System | This privilege provides the user the ability to edit URL and study settings in SCE. |
| Schedule Reports | System | This privilege provides the user with the ability to schedule reports to run. This privilege requires the 'Run Reports' privilege. |
| Specifications | System | This privilege provides the user with access to the Specifications module, where the user can view and manage specifications for dataset mapping or exception listings for each study. Users will only see and have access to specifications for the studies for which they have permissions. |
| Study Access | Studies | This is available for Unlicensed Users. Selecting 'Study Access' adds the ability to limit access to Issues for specific studies, which are listed under the Privileges tab with 'View' selected. |
| Study Configure | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege provides the user with access to create a new study or update any of the configurations related to a study. This privilege also provides the user with the ability to use eForms Designer, create a data Snapshot within elluminate, and configure Data Central studies. |
| System Configure | System | This privilege provides the user with access to the Configuration module, where a user can configure various URL level objects, such as Compounds, Phases, Staging Areas, Data Marts, etc. This privilege is also required for users who will upload to the Standards module. |
| Task Edit | System | This privilege provides the user with the ability to edit and delete all tasks. By default, users can edit and delete only their tasks; with this privilege, they can edit and delete tasks created by other users. |
| Template Configure | System | This privilege provides the user with the ability to create and manage templates. Templates can be used in the creation and management of Studies, Data Sources, and Import Definitions. |
| Unlicensed User | Assigned Issues | This privilege allows non-elluminate users to access Issues that are assigned to them so they can respond. They will have no other access to the elluminate platform. |
| Validator Configure | Studies, Global Data Stores, Compounds, Programs or Therapeutic Areas | This privilege provides the user with the ability to create Validator definitions. This privilege requires the 'Validator View' privilege to work. |
| Validator View | Studies, Global Data Stores, Compounds, Programs or Therapeutic Areas | This privilege provides users to view Validator definitions, run or schedule them, and see the results validation jobs. |
| View | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | This privilege allows the user to view a study on the elluminate Home Page. The View privilege has the highest precedence; therefore, it must be selected for a study to display on the user’s landing page. Most actions cannot be completed without the 'View' privilege selected. |