elluminate privileges control access to products, studies, and specific functionality. Training requirements vary based on assigned privileges and licensed products.
Use the following table to review each privilege, where it applies, its definition, and the associated eLearning training requirements.
* Optional; provides supplemental information.
** Required when the associated product is licensed and the applicable privilege is assigned.
| PRIVILEGE | APPLIES TO | DEFINITION | TRAINING |
|---|---|---|---|
| Administer | System | Access all system, product, and study functionality, including user configuration. | • All eLearning Courses |
| Analytics | Studies, Global Data Stores, Compounds, Programs, Therapeutic Areas, and Apps | Access specific apps and published sheets within Analytics. Create Bookmarks and Stories without modifying Analytics visualizations. The Apps accordion displays apps deployed to the URL and allows administrators to specify access for users or user groups. | • elluminate Overview • Analytics: Core Training • Analytics: CDA** • Analytics: CTOA** • Sample Management Analytics** |
| Analytics Customize | System | Create new Analytics data models or modify existing Analytics data models, such as CDA. | • elluminate Overview • Analytics: Core Training • Analytics: Create Custom Analytics • Analytics: Create & Publish Stories** • Analytics: CDA** • Analytics: CTOA** • Analytics: Sample Management Analytics** |
| Analytics Edit | System | Create, modify, and publish sheets within Analytics visualizations. Requires the Analytics privilege. | • elluminate Overview • Analytics Advanced: Creating New Visualizations & Sheets |
| Apps Hub Developer | System | Build and maintain custom Shiny applications from the Apps page in SCE. Applications can be built in R or Python and can connect to elluminate data stores. | In development |
| Apps Hub Publisher | System | Publish custom Shiny applications managed from the Apps page in SCE and make them available to authorized users in Apps Hub. | In development |
| Apps Hub Viewer | System | Access Apps Hub to discover and launch published custom Shiny applications. | In development |
| Blinded Data Configure | Studies | Configure blinded and unblinded data for a study. Does not provide access to view blinded data. | • elluminate Overview • System Administration |
| Blinded Data View | Studies | View blinded data. By default, blinded data is not visible or accessible. Can only be assigned at the user level and cannot be added to a group. | • elluminate Overview |
| Data Central | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Access Data Central. Available actions depend on the assigned reviewer role configured in Data Central Configuration. | • elluminate Overview • Data Central: Core Training • Data Central: Working with Data* • Data Central: Actioning Issues & Queries* • Data Central: Study Cards* • Data Central: Working with Visualizations* • Data Central: Folders* |
| Data Central Designer | System | Save and manage public Workspaces, public Visualizations, and public Filter Sets within a defined folder structure and configure security. Create and manage Patient Profiles, Advanced Filters, and Data Cuts. | • elluminate Overview • Data Central: Core Functionality • Data Central: Building new Visualizations • Data Central: Folders • Patient Profile Configuration |
| Data Quality | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Complete validations within Data Quality. | • elluminate Overview |
| Delete Study | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Delete a study. | • elluminate Overview • System Administration |
| eDrive Global Read | System | Access the root folder in eDrive, including folders outside a study. Requires the eDrive Read privilege to access study folders. | • elluminate Overview • eDrive: Core Training* |
| eDrive Global Read Write | System | Read and write to the root folder in eDrive, including folders outside a study. Requires the eDrive Read privilege to access study folders. | • elluminate Overview • eDrive: Core Training* |
| eDrive Read | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Read study folders and all subfolders of the selected study. | • elluminate Overview • Using eDrive* |
| eDrive Read Write | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Read and write to study folders and all subfolders of the selected study. | • elluminate Overview • eDrive: Core Training* |
| eForms | System | Access eForms and view, enter, edit, and delete data entered into an eForm. This is a legacy privilege. | • elluminate Overview |
| eIQ Review | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Access eIQ Review in Data Central. | • elluminate Overview • eIQ Review: Core Training • eIQ Review: Configuration Training* |
| Exporter | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Export data from elluminate in Excel, CSV, delimited tilde, or delimited vertical bar formats. Requires the SAS Exporter privilege to export SAS formats. | • elluminate Overview • Exporter* |
| Global Library Configure | System | Manage the Global Library used in Mapper. | • elluminate Overview • Global Library |
| Global PDAP Configure | System | Access the Protocol Deviation Assessment Plan (PDAP) under Metadata Management and configure the Global PDAP. | • elluminate Overview • Protocol Deviation: Configuration Training |
| Importer | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Import data into elluminate. Run an existing import definition or a manual import. | • elluminate Overview • Importer |
| Issue Administration | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Edit Issue Text and Due Date within Issues and Data Central. Upload an Excel file containing addressed open issues. | • elluminate Overview • Data Central: Core Training • Data Central: Actioning Issues & Queries |
| Manage Users | System | Access User Management to administer user information and elluminate access. | • elluminate Overview • User Administration |
| Mapper | System | Access Mapper to build transformations. | • elluminate Overview • Mapper: Core Training • Mapper: Data Central** • Mapper: CDA / SDTM** • Mapper: CTOA** |
| Mapper Advanced | System | Create Dynamic Mapping Templates. | • elluminate Overview • Mapper: Core Training • Mapper: Data Central** • Mapper: CDA / SDTM** • Mapper: CTOA** |
| Metadata Editor | System | Edit available study metadata and remove domains. | • elluminate Overview • System Administration |
| ODR Analytics | System | Access the Operational Data Repository in read-only mode and access the Operational Oversight app within Analytics. | • elluminate Overview • Operational Oversight |
| ODR Configure | System | Configure picklists and fields within form details and listings in the Operational Data Repository. Does not provide access to the Analytics Operational Oversight app. | • elluminate Overview • ODR: Configuration Training |
| ODR Read | System | Access the Operational Data Repository in read-only mode. | • elluminate Overview • ODR: Read Only Training |
| ODR Read Write | System | Read and write data in the Operational Data Repository. Does not provide access to the Analytics Operational Oversight app. | • elluminate Overview • ODR: Read Write Training |
| Patient Profile Configure | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Create and manage patient profiles without the Data Central Designer privilege. | • elluminate Overview • Data Central: Core Training • Patient Profile Configuration |
| Patient Profile View | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | View the configured Graphical Patient Profile within Data Central. This privilege is no longer required for new users but remains available for legacy users. | • elluminate Overview • Data Central: Core Training |
| Protocol Deviation Edit | Studies | Access the study Protocol Deviations Dashboard and manually add or edit protocol deviations. | • elluminate Overview • Protocol Deviation: Read Write/Edit Training |
| Protocol Deviation View | Studies | View the Protocol Deviations Dashboard in read-only mode. | • elluminate Overview • Protocol Deviation: Read/View Only Training |
| RACT Assessment Read Only | Studies, Compounds, Programs, and Therapeutic Areas | View RACT data in read-only mode. | • elluminate Overview • RACT: Read Only Training |
| RACT Assessment Read Write | Studies, Compounds, Programs, and Therapeutic Areas | Access RACT and conduct assessments. | • elluminate Overview • RACT: Read Write Training |
| Read Only User | System | Access the elluminate platform in read-only mode for visibility into audit events across all users and actions in the URL. | • elluminate Overview |
| RBQM | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Access Risk Based Quality Management (RBQM) in Data Central. | • elluminate Overview • RBQM: Core Training |
| Reporting DB | System | Access the Reporting Database for studies configured for the Reporting Database. Requires a Reporting Database username and password. | In development |
| Risk Management Configuration | System | Access Configuration within Risk Management to configure RACT and global-level RBQM items. Includes access provided by the RACT Assessment Read Write and RBQM privileges. | • elluminate Overview • Risk Management: Configuration Training |
| Run Reports | System | Access Reports and run administrative reports. | • elluminate Overview • System Reports: Access and Run System Reports in elluminate* |
| SAS Exporter | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Export data in SAS-specific formats, including XPT and sas7bdat. Requires the Exporter privilege. | • elluminate Overview • Exporter* |
| SCE | System | Access SCE and navigate to SCE components. | • elluminate Overview • SCE: Core Training |
| SCE Configure | System | Edit URL and study settings in SCE. | • elluminate Overview • SCE: Configuration Training |
| Schedule Reports | System | Schedule reports to run. Requires the Run Reports privilege. | • elluminate Overview • System Reports: Access and Run System Reports in elluminate* |
| Specifications | System | View and manage specifications for dataset mapping or exception listings. Access is limited to studies for which the appropriate permissions are assigned. | • elluminate Overview • Specifications* |
| Study Access | Studies | Limit issue access for Unlicensed Users to specific studies listed under the Privileges tab with View selected. | No training required. |
| Study Configure | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | Create new studies or update study configurations. Use eForms Designer, create data Snapshots, and configure Data Central studies. | • elluminate Overview • System Administration • Data Central: Configuration Training** • eIQ Review: Configuration Training** • Patient Profile Configuration** • RBQM: Configuration Training** • IDRP: Configuration Training** |
| System Configure | System | Access Configuration to configure URL-level objects such as Compounds, Phases, Staging Areas, and Data Marts. Required to upload to Standards. | • elluminate Overview • System Administration |
| Task Edit | System | Edit and delete all tasks, including tasks created by other users. | • elluminate Overview • Tasks: Create and Run Tasks in elluminate |
| Template Configure | System | Create and manage templates used to create and manage Studies, Data Sources, and Import Definitions. | • elluminate Overview • System Administration • Importer • Validator |
| Unlicensed User | Assigned Issues | Access Issues assigned to the user and respond to them. No other elluminate platform access is provided. | • elluminate Overview* • Unlicensed Users Training* |
| Validator Configure | Studies, Global Data Stores, Compounds, Programs, or Therapeutic Areas | Create Validator definitions. Requires the Validator View privilege. | • elluminate Overview • Validator |
| Validator View | Studies, Global Data Stores, Compounds, Programs, or Therapeutic Areas | View Validator definitions, run or schedule them, and view validation job results. | • elluminate Overview • Validator |
| View | Studies, Global Data Stores, Compounds, Programs, and Therapeutic Areas | View assigned studies and global data stores on the Studies and Global Data Stores pages. Required with other applicable privileges to access and perform permitted actions within a study or global data store. | • elluminate Overview |