Permissions: Data Central: Allows licensed users to access the Data Central module and view Graphical Patient Profiles.

Data Central Designer: Allows users to save and manage public workspaces, visualizations, filter sets within a defined folder structure and configure the security, as well as configure data cuts. It also allows users to create and manage Graphical and Workbook Patient Profiles.

Patient Profile Configure: Allows users without the Data Central Designer privilege to create and manage Graphical and Workbook Patient Profiles.

Study Configure: Allows administrative users to perform study-level configuration for studies in elluminate, including Data Central. This is required for Data Central configuration (including RBQM and eIQ Review). 

View: Allows licensed users to see their studies in elluminate. This is required for all Data Central users.

Data Central provides a single, integrated platform for reviewing and managing all study data, regardless of its source. It offers Data Managers, Medical Reviewers, and other study team members a more complete view of subjects across all data sources. This enables efficient data review, cleaning, and the production of a high-quality database in near real-time.  

Studies enabled for the Integrated Data Review Plan (IDRP), RBQM, eIQ Review, Protocol Deviations, and Clean Progress Tracking are configured and viewed within Data Central.

• For details about using and configuring the Integrated Data Review Plan (IDRP), see the help articles: Configure the Integrated Data Review Plan (IDRP) in Data Central Configuration and Use the Integrated Data Review Plan (IDRP) in Data Central. 
• For details about configuring and using RBQM, see help articles in the RBQM section.
• For details about configuring and using eIQ Review, see the help articles in the eIQ Review section.
• For details about configuring and using Protocol Deviations, see help articles in the Protocol Deviations section.

Note: Data Central supports the Medidata Rave EDC system and, for Rave studies, requires Medidata Rave release 2016.5.3 or higher.  

Note: Data Central supports the assignment of issues to unlicensed elluminate users with Data Central privileges. See information on Issues to learn more about unlicensed elluminate users.

Data Central provides users with a dynamic workspace experience through easy navigation and efficient ways to group related data for comprehensive review.

Key functional capabilities include:

• Predefined and customizable workspaces to support common review tasks
• Multiple search and filtering options supporting individual and multiple record review
• Ability to sort records by multiple columns
• Ability to fix one or more columns as stationary while scrolling horizontally
• Annotation feature for adding inline observations and flagging protocol deviations
• Highlights feature for highlighting cells, rows, and column headers
• Ability to mark an entire domain or record as reviewed in a single operation
• Ability to create ad hoc charts and data listings
• Ability to assess risk using the RBQM dashboards
• Ability to review data using AI/ML models using eIQ Review

Data review actions include the ability to:

• Access and manage Review Plan objectives
• Mark records as reviewed / unreviewed
• Review programmed listings based on complex edit checks and take action
• Review, answer, close, and reopen EDC queries directly from within elluminate for studies with 2-way integration
• Perform cumulative data review and raise manual queries for studies with 2-way integration
• Open, answer, or close data or domain issues and assign to study team members for investigation
• Provide feedback on model predictions in eIQ Review

Access Data Central

Access the Data Central Studies page via the Platform Menu under Data Review. For a specific study, open it from Study Management in the Platform menu or by using the drop-down next to Details in the master header of the study details view.

Access the Data Central Studies Page from the Platform Menu

1. Click the 9-dot icon to open the Platform Menu. The Platform Menu opens.
2. Click Data Central under Data Review.
   
   
   The Data Central Studies page displays Data Central enabled studies. 
   

Access a Data Central Study from the Platform Menu

Another way to access a study in Data Central from the Platform Menu.

1. Click the 9-dot icon to open the Platform Menu. The Platform Menu opens.
2. Confirm Studies is selected in the top center of the Platform Menu. Studies is selected by default, if Global Data Stores is selected, click Studies.
   
3. Click Data Central under Study Management (left side of menu).

4. Select a study from the right side of the menu. The Data Central default workspace opens for the selected study.

   Tip: To open the most recently viewed study, hover over and click the icon to the right of Data Central under Study Management.

Access a Data Central Study from the Study Details View

Another way to access Data Central is from within a study. 

1. Click a Study Name from the Studies page.
2. Click the drop-down next to Details in the master header.
   
3. Select Data Central from the drop-down. Data Central opens displaying the default workspace.

Navigate the Data Central Studies Page

A. Master Header

• 9-dot icon: Click to open the Platform Menu. 
• elluminate logomark: Click to return to the Studies page or the configured Home Page.
• Data Central Studies (blue badge): Indicates the active page. The blue badge displays the number of studies.
• Search: Defaults to search by Name. Use the drop-down to select Description, Therapeutic Area, Compound, Phase, Type, or Program. Enter a search term to display matching studies automatically. The blue badge displays the number of matching results.
• Configuration icon: Click to select Study Group Configuration. See Configure Study Groups for details.
• Favorite icon: Click to display favorite studies. Click the Star icon on a study card to add the study to favorites. Click again to return to all studies.
• Quick Filters icon: Click to open the filter menu. Filter studies by Data Central configuration and feature enablement, including Data Central Configured, RBQM Enabled, eIQ Review Enabled, ODR Enabled, Clinical Data Analytics Enabled, Clinical Trial Operational Analytics Enabled, and Source Data Analytics Enabled. Click Clear to display all studies.
• Groups icon: Click to select a group and subgroup. The view displays only studies assigned to the selected subgroup in Study Group Configuration. Click again to change the group or subgroup, or click Clear to display all studies.
• Card View icon: Displays studies in card view. This is the default view.
• Grid View icon: Displays studies in a list view. Standard elluminate grid functionality applies. Click a column header to sort ascending or descending or to filter. Right-click a column to fix or unfix it to the left or right.
• Filters icon: Indicates active filters in Grid View when shaded. Click to clear all filters or individual filters.
• Help icon: Click to open a drop-down and select an option to access the Help Center, Community, Learning Portal, Support, Privacy Policy, Legal Notices, or About, which displays the current version number.

B. Study Card not yet configured for Data Central.

C. A Study Card configured for Data Central.

Configure Study Groups on the Data Central Studies Page

Users can customize the display of study cards on the Data Central Studies page by creating and managing study groups.

Add a Study Group and Subgroup

1. On the Data Central Studies page (card or grid view), click the Configure icon in the toolbar.
2. Select Study Group Configuration. The Study Groups window opens.
   
3. Click the Add Custom Group icon. 
4. Enter a New Custom Group name and click the checkmark.
5. Next to the Group Name, click the Add Subgroup icon.
   
6. Enter the New Subgroup name and click the checkmark.
7. Select the Subgroup name and select the studies to include.
   
8. Click Save. 

Edit a Study Group or Subgroup

1. On the Data Central Studies page (card or grid view), click the Configure icon in the toolbar.
2. Select Study Group Configuration. The Study Groups window opens.
3. Select the Group or Subgroup to edit.
4. Click the Edit icon.
5. Update the name or study assignments.
6. Click Save. 

Delete a Study Group or Subgroup

1. On the Data Central Studies page (card or grid view), click the Configure icon in the toolbar.
2. Select Study Group Configuration. The Study Groups window opens.
3. Select the Group or Subgroup to delete.
4. Click the Delete icon.
5. Click Save. 

View and Customize Study Cards

Each study card displays a default set of metric tiles with indicators based on the user's assigned Data Central reviewer role. User's with different roles across studies may see different indicators. These indicators are customizable.

Metric tiles display as 'n of x.' For example, a study card showing '39/969 Answered Issues,' indicates 39 of 969 issues are answered. The progress bar visually represents completed work versus remaining work. 

Custom metrics, such as Uncoded AEs and CMs, can be configured and displayed in addition to standard metrics. 

If a study uses the Operational Data Repository (ODR) and data are available, the study card includes the latest and next milestone metrics. 

If RBQM is enabled for a study, the study card includes the RBQM Direct Link tile.

Tip: Study cards display 8 tiles by default. Click the dots or arrows at the bottom of the card to view additional tiles.

Study Card Layout

Study cards display the following information and controls.

Study Name

• Studies not yet configured for Data Central display a red triangle icon. Click the icon, or click the Configuration icon and select Data Central Configuration, to open the Data Central Configuration window.

• Configured Data Central studies display the study name in blue text. Click the study name to open the study in Data Central. 

  Not Yet Configured

  Configured

Icons at the Top Right of the Study Card

• Study Details: Click to open the Study Details window.
• Expanded View: Click to expand the study card. 
  • In expanded view, click a tile to open the associated listing in a new tab.
  • For studies with ODR enabled and milestone data, the study timeline displays in expanded view.
• Configuration: Click to select Study Card Configuration or Data Central Configuration. 
  • Study Card Configuration: A default set of indicators is selected. To customize the study card view, refer to the Configure Study Card section below.
  • Data Central Configuration: Opens the Data Central Configuration window.
• Favorite: Click the star icon to mark a study as a favorite. Then, use the Favorite icon in the master header to display only favorite studies. 

Study Details Displayed on the Card

• Number of Sites and Subjects: Displays the number of sites and subjects participating in the study.
• Last Import Status: Displays the most recent successful and failed imports. 
• Study Type and Phase: Displays the study type and phase.

Metric Tiles and Navigation

Default metric tiles display based on the user's Data Central reviewer role. Click a metric tile on a configured Data Central study to open the associated listing in a new tab.

• Objectives To Review: Navigates to the Review Plan Dashboard.
• Total (All Roles) To Review or Reviewed: Navigates users with a Data Central read-only role to the Records Review Summary panel.
• Records Reviewed, Records to Review, Records to Review Percent, and Records Updated Since Review: Navigates users with a Data Central reviewer role to the Records Review Summary panel, sorted by the selected metric.
• Open / Answered / Closed / Cancelled Issues: Navigates to the Issues listing filtered by the selected status.
• Open / Answered / Closed / Past Due Open Queries: Navigates to the Queries listing filtered by the selected status.
• Latest and Next Milestones: Displays when milestone data are available in the Operational Data Repository.
• RBQM Direct Link: Click to open the RBQM Overview dashboard.

Opening a Study

When a study opens, Data Central displays the default workspace. The default workspace is customizable. If no workspace is configured, the 'Default' workspace, typically the Subjects listing, displays. System administrators can configure the default workspace per URL.

Configure Study Card

Each study card displays a default set of indicators that can be customized.

1. Click the Configuration icon on a study card.
2. Select Study Card Configuration. The Customize Study Card window opens with the default indicators selected.
   
3. Select the study card indicators to display. Use the right scrollbar to view all options. 
   • Up to eight tiles display on the study card. Click the dots or arrows at the bottom of the card to view additional tiles.
4. Reorder tiles by dragging the 6-dots to the right of each indicator.
5. Click Save.

Navigate the Data Central Workspace

The Data Central workspace provides flexibility for reviewing study data. Users can open multiple sheets containing panels, listings, and visualizations within a single browser session. This layout enables review and management of data on one screen, while allowing quick access to additional sheets within the workspace. Hovering over workspace elements, such as badges, column headers, and icons, displays labels with additional detail or available actions.

Initial Workspace View

When Data Central opens, a predefined workspace displays. Depending on configuration, the system default workspace or a role-specific workspace appears. The workspace assignment occurs during study configuration in Data Central.

Left Navigation

The left navigation organizes workspace content into sections.

Study Status includes:

• Subjects
• Queries, available when integrated with an EDC that provides query data, such as Medidata Rave, Veeva, or InForm
• Issues
• Review Plan

Data Exploration includes:

• Protocol Deviations, if enabled
• RBQM, if enabled
• eIQ Review, if enabled
• Visualizations
• Data, including Data Stores and listings

Opening Panels and Views

Click Subjects, Queries, or Issues to open the corresponding panels on the active sheet. Subjects opens by default if not already displayed.

Click Review Plan to display it over the left navigation.
Alternatively, hover between Review Plan and the badges, then click the three-dot icon to access the Review Plan Dashboard, Review Plan Panel, or Review Plan Details.

Click the side arrows next to Protocol Deviations, RBQM, eIQ Review, Visualizations, or Data to expand each section and make selections.

Click the Open Records Review Summary icon, shown as a clipboard with a checkmark to the right of Data, to open the Records Review Summary panel.

Collapsing and Expanding the Left Navigation

The left navigation supports an icon-only collapsed view. Click the drag handle on the panel edge or the Toggle Side Navigation icon in the Study Status header to expand or collapse the panel.

When collapsed, the left navigation displays icons only, allowing quick access to sections while maximizing workspace screen area.

Study Metrics - Badges

In the left navigation, key study metrics display as badges next to Subjects, Queries, Issues, and Review Plan.

• Subjects: Displays the total number of subjects (blue) and the number of filtered subjects (orange) for the current view.
• Queries: Displays the count of answered queries (green) and open queries (red).
• Issues: Displays the count of answered issues (green) and open/in-progress issues (red).
• Review Plan: Displays the number of completed objectives (green) and objectives that are not started or in progress (red).

Badges Within Panels

Each open or docked panel displays a badge showing the number of available records. The count reflects any applied filters, including default and user-defined filters.

Clicking the badge on an open or docked data or listing panel opens a popout that displays the number of records and applied filters.

Clicking a listing name opens a popout that displays details such as Data Store, Domain, Last Refresh, Data Date, Source, Total Records, number of records Reviewed, number of records Updated Since Reviewed, and number of records Not Reviewed.

Subjects Panel

The Subjects panel displays a configurable listing of subjects for the study. The panel can also be configured as a Clean Participant Tracker. 

If the default workspace is configured, the listing typically appears on the Default sheet (bottom-left). However, this may change if a role-based workspace has been designated.

Subjects Listing Columns

The Subjects listing includes the following default columns:

• Comments: Displays a hyperlinked number indicating the number of comments for the record. Click the number to open the Comments window to view existing comments and add new comments.
• [Role] Records to Review: Displays a hyperlinked number indicating the number of records the role must review, including records with New and Updated Since Reviewed statuses. Click the number to open the Records Review Summary panel, filtered to show only domains containing records for that subject that require review for the user’s role.
• Open / In Progress and Answered Issues: Display hyperlinked numbers indicating the count of open or in-progress issues and answered issues. Click a number to open the Issues panel, filtered by the selected status for the subject.
• Open and Answered Queries (if applicable): Display hyperlinked numbers indicating the count of open and answered queries. Click a number to open the Queries panel, filtered by the selected status for the subject.
• Subject: Displays the subject identifier.
• Site: Displays the site associated with the subject.

Additional columns, such as Clean Status and other operational counts, are available. Listing columns are fully configurable to meet study-specific requirements.

Actions and Features

Use the panel toolbar or right-click options to perform the following actions on selected subjects:

• Open a record Details view.
• Create an issue or add a comment.
• Add annotations (annotation columns are located at the far right, if available).
• Configure or generate Workbook Patient Profiles (downloadable Excel file).
• View a Graphical Patient Profile.
• Export the Subjects listing, with or without comments.
• Open Subjects Settings to hide columns, manage annotation columns, and manage column and row highlighting.
• Search for a column by name or label and select it from the drop-down.
• Use the eye icon to filter subjects in other panels.
• Use the Maximize icon to view the panel full screen; use the Restore icon to return the panel to its original size.
• Use the X icon to close the panel.

For details on the panel toolbar icons, see Toolbar Icons & Actions below.

Users can also apply advanced filters targeting the domain used to configure the Subjects listing and other relevant domains. 

Note: Use the panel scrollbar to view all columns. Use filter and sort options, as well as the left and right column-fixing features, to customize your view.

Navigate Open Panels on a Sheet

Records Review Summary Panel

The Records Review Summary panel displays review metrics for the logged-in user and for all users configured for the study. Users with a Data Central reviewer role see two table views: the 'My Role' view (default), and the 'All Roles' view. 

The 'My Role' view enables users to focus on their assigned role and quickly identify required review work. The 'All Roles' view provides a summary of review progress and remaining work across all roles. Both views will display the Domain Name, Domain Label, Data Store, and Total Records for each domain. The review metrics differ by view.

Access the panel from a review metric tile on the Data Central Studies page or by clicking the clipboard with checkmark icon next to Data within the Data Central study.

Note: Metric tiles vary based on the assigned Data Central reviewer role.

In the 'My Role' view, the panel title displays the reviewer role abbreviation in parentheses for reference and validation.

Click the switch icon to display the 'All Roles' view. 

Tip: Use filtering options, including right-clicking a field to filter rows by value.

In the 'All Roles' view, each metric displays the role abbreviation in parentheses in the column header for the role it pertains to.

For roles not configured for review in a specific domain, a dash displays.

All columns support sorting and filtering.

Click a Domain Name to open the corresponding domain listing.

Master Header and Sheet Icons & Actions

Icon/Button	Items	Description/Action
	9-dot icon	Click to open the Platform Menu.
	elluminate logomark	Click to return to the Studies page or the defined landing page.
	Selected Study drop-down	Displays the current study. Click the down arrow to view and select other studies.
	Selected Module drop-down	Displays the current module. Click the down arrow to view and select other modules within the study.
	Filter Panel icon	Displays the number of applied filters and opens the Filter Panel in the left navigation. The Filter Panel allows users to view applied filters in one location and access Filter Sets, including Advanced Filters..
	Data Cuts icon	Click to apply an enabled Data Cut or configure Data Cuts. Configuration requires the Data Central Designer privilege.
	Workspace drop-down	Displays the current workspace. When a study opens in Data Central, the predefined role-based workspace or the system 'Default' workspace displays. Click the down arrow to view and select other available workspaces, including saved private workspaces, public workspaces, and elluminate pre-defined workspaces located in the elluminate folder, such as Audit Trail Review, Clean Progress Tracking, and Review Plan Dashboard.
	Export icon	Click to export Graphical Patient Profiles or listings currently in view.
	Notifications icon	Click to view and manage notifications for completed exports, such as Workbook Patient Profiles or GPP and listing exports.
	Manage icon	Click to configure and manage folders used for workspaces, visualizations, and filter sets. Requires the Data Central Designer privilege.
	Data Central Settings icon	Click to open the Data Central Settings window. The General Settings section includes options to Use User Workspace, set the Number of visible rows in a table, and Use Default Filters. If permissions allow, the Data Central Settings, Workspace Defaults, and Configure Data Central Settings options display.
	Help icon	Click to open a drop-down menu to access the Help Center, Community, Learning Portal, Support details, Privacy Policy, Legal Notices, and About, which displays the current version number.
	elluminate Assist icon (if enabled)	Click to open the GenAI-enabled text-to-SQL chatbot. The chatbot uses large language models to interpret natural language questions related to SDTM safety data and generates results, relevant SQL queries, and explanations.
	Add Sheet icon (bottom left)	Click to add another sheet to the workspace. Multiple sheets can be added.
	All Sheets icon (bottom left)	Click to view a list of all sheets, including hidden sheets.
	Sheet name (bottom left)	The active sheet displays an orange underline. Click another sheet to switch views. Click the three-dot menu to rename, copy, delete, clear contents, or hide the sheet.

Toolbar Icons & Actions

Panel toolbars contain icons that represent available actions. Hover over an icon to display a tooltip describing its function. Right-clicking a record also provides access to these actions via a context menu.

Additional details about each icon appear in the sections where the icons are used.  

Icon	Icon Label	Action
	Previous / Next Page	Click to move to the previous or next page.
	Details	Click a highlighted record to open a new window displaying Subject Detail fields, related issues, queries, and comments, as configured.
	Create	Click to create an issue, add a comment, or create a query. Available options depend on the panel, domain, data point, and study configuration.
	Workbook Patient Profile	Click to download a Workbook Patient Profile (WPP) for the highlighted subject. Users with the Study Configure privilege can also select Configure to configure the profile.
	Graphical Patient Profile	Click to open a Graphical Patient Profile (GPP) for the highlighted subject. Users with the Study Configure privilege can also select Configure to configure the profile.
	Export	Click to export the panel or listing. All rows are included, not only displayed rows. If filters are applied, only filtered results are exported. Additional options may be available depending on the panel or listing, such as exporting data for the current role or all roles.
	Configure	Click to configure domain settings. Available options depend on system privileges.
	Filter	The Filter icon appears in multiple locations. Listing badges indicate whether filters are applied to the panel. Column headers indicate whether a filter is applied to a specific column.
	Action	Click to action queries or issues.
	Filter subject in other panels	Highlight a record, then click to filter all other open panels on the sheet to that subject. The originating panel continues to display all records. When active, the icon is highlighted. Click again to clear the filter.
	Search	Locate a column in a data or custom listing. Click the Search icon, enter part of a column name or label, and select it from the list.
/	Maximize / Restore	Click to maximize a panel. In maximized view, click Restore to return the panel to its previous open or docked state.
	Dock Item	Click to dock a panel or listing to the sheet.
	History	Click to view field history. For Query details, displays the query history from the EDC (if available). For Data and Listing details, it displays the history of the highlighted field in the EDC.
	View Record in Rave EDC	Click to open the associated record in Rave EDC for Rave studies.
	Review / Review Operations	Click Review to mark records as reviewed. Click the down arrow next to Review to access additional review options.
	Data Variance	Click to define parameters for a data variance analysis (view new, updated, and deleted records within a date range).
	Previous / Next Record	Click to move to the previous and next record.
	Create Issue	In Details view, click to create an issue.
	Edit	In issue Details view, click to edit the issue.
	Start Progress	Click to progress an open issue. (If configured for the URL.)
	Answer Query/Answer Issue	In the query Details view, click to answer a query if supported by the EDC and study configuration. In the issue Details view, click to answer the issue.
	Close Query / Close Issue	In the query Details view, click to close a query if supported by the EDC and study configuration. In the issue Details view, click to close the issue.
	Close as Irresolvable	In the issue Details view, click to close the issue as irresolvable. This is a sub-status of Closed.
	Move Issue to Pending	In the issue Details view, click to move an issue to Pending. This is a sub-status of Open.
	Reopen Issue	Click to reopen a closed issue.
	Cancel Query / Cancel Issue	In the query Details view, click to cancel a query if supported by the EDC and study configuration. In the issue Details view, click to cancel the issue.
	Requery	In the query Details view, click to requery to the EDC, if supported by the EDC and study configuration.
	Save	Click to save changes.
	Save as...	When creating a new workspace, click Save As to open the Configure Workspace window
	Zoom Out	In a Graphical Patient Profile, click to reset the profile after moving timelines.
	Alert	In a domain listing, indicates an improper domain key definition. Hover to view details. In the Details view, indicates a field value changed since the last review.
	Close	Click to close the panel or remove it from the sheet.