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 to open the study details.
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 your configured Home Page).
• Data Central Studies (blue badge): Indicates you are on the Data Central Studies page; the blue badge displays the number of studies.
• Search: The default search is by Name. Use the drop-down to select Description, Therapeutic Area, Compound, Phase, Type, or Program. Enter a search term; matching studies will appear automatically. The blue badge shows the number of matching studies.
• Configuration icon: Click to select Study Group Configuration. See Configure Study Groups for details.
• Favorite icon: Click to view studies marked as favorites. Click the Star icon on a study card to add a study to favorites. Click again to show all studies.
• Quick Filters icon: Click to open a drop-down and select from options that filter studies by Data Central Configured, RBQM Enabled, eIQ Review Enabled, ODR Enabled, Clinical Data Analytics Enabled, Clinical Trial Operational Analytics Enabled, or Source Data Analytics Enabled. Select Clear to see all studies.
• Groups icon: Click to select a group and then a subgroup. Only studies added to the selected subgroup in Study Group Configuration will display. Click again to select a different group / subgroup, or Clear to see all studies.
• Card View icon: This is the default (shaded). 
• Grid View icon: Click to view study details in a list. Standard elluminate listing functionality is available: click a column header to sort ascending / descending or filter; right-click to fix / unfix columns to the left or right.
• Filters icon: This icon is shaded when filters are applied in Grid View. If shaded, click to clear all 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 [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 their view of study cards on the Data Central Studies page by 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 (plus sign) icon. 
4. Enter the New Custom Group name and click the checkmark.
5. Next to the Group Name, click the Add Subgroup (plus sign) icon.
6. Enter the New Subgroup name and click the checkmark.
7. Highlight the Subgroup name and select the studies to be included.
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. Click to highlight the Group or Subgroup name to edit.
4. Click the Edit icon.
5. Make changes.
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. Click to highlight the Group or Subgroup name 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 for different studies will see different indicators. These indicators are customizable.

Metric tiles display as 'n of x.' For example, the screenshot below shows study Clintek-010 displaying '39/969 Answered Issues,' indicating 39 of 969 issues have been answered. The progress bar visually represents completed 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 will include the latest and next milestone metrics. 

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

Tip: Study cards display 8 tiles by default; click the dots or arrows at the bottom to see additional tiles.

Study cards display the following:

• Study Name
   
  • Studies not yet configured for Data Central display the red triangle icon. Click this icon, or the Configuration icon (then select Data Central Configuration), to access the Data Central Configuration window.

  • Configured Data Central studies appear in blue text. Click the hyperlinked study name to open it in Data Central. 

    Not Yet Configured

    Configured

• Icons at the top right
  • Study Details: Click to open the Study Details window.
  • Expanded View: Click to expand the view. 
    • In expanded view, click a tile to open the associated listing in a new tab.
    • In expanded view, for studies with ODR enabled and milestone data, view the study timeline.
  • Configuration: Click to select Study Card Configuration or Data Central Configuration. 
    • Study Card Configuration: A default set of indicators is selected. To customize your study card view, refer to the Configure Study Card section below.
    • Data Central Configuration: Click to open 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 show only your favorite studies. 
• Number of Sites and Subjects: Under the study name view the number of sites and subjects  participating in the study.
• Last Import: Success / Failure: Displays the last successful and failed imports. 
• Study Type and Phase: Displays the type and phase of the study.
• Metric tiles: Default metric tiles will display based on the user's Data Central reviewer role.
  • Click a metric tile of a configured Data Central study to open the associated listing in a new tab.
    • Objectives To Review: Navigates the user to the Review Plan Dashboard.
    • Total (All Roles) To Review or Reviewed: Navigates a user 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 a user with a Data Central reviewer role to the Records Review Summary panel sorted based on the selected metric.
    • Open / Answered / Closed / Cancelled Issues: Navigates to the Issues listing filtered for the selected status.
    • Open / Answered / Closed / Past Due Open Queries: Navigates to the Queries listing filtered for the selected status.
  • See the Latest and Next Milestones if appropriate data are entered into the Operational Data Repository.
  • Click the RBQM Direct Link to access the RBQM Overview dashboard.

Data Central opens to the selected study, displaying the default workspace (customizable). If no workspace is configured, the 'Default' workspace (usually the Subjects listing) appears. System administrators can configure this per URL.

Configure Study Card

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

1. Click the Configuration icon on a study card.
2. Select Study Card Configuration. A Customize Study View window opens with the default set of indicators selected.
   
3. Select your preferred study card indicators; use the right scrollbar to view all options. Up to eight tiles display; click the dots or arrows at the bottom to see more.
4. To reorder the tiles, use the 6 dots to the right of each indicator.
5. Click Save.

Navigate the Data Central Workspace

The Data Central workspace allows for flexibility in customizing how a user reviews study data. Multiple sheets with multiple panels, listings, and visualizations can be opened within one browser so that viewing and managing data on a sheet are all on one screen, and additional sheets are easily accessed within the workspace, adding efficiencies in data review. Hovering over individual items on the workspace, such as badges, column headers, and icons, provides a label with detail or action.

Initial Workspace View

A pre-defined workspace is displayed upon opening Data Central. Depending on the configuration, either the system default workspace or a role-specific workspace may appear. The user’s workspace is assigned during the configuration of the study in Data Central.

Left Navigation

Items in the left navigation under Study Status include: Subjects, Queries (available if integrated with an EDC such as Medidata Rave, Veeva, or InForm that provides query information), Issues, and Review Plan. Items under Data Exploration include: Protocol Deviations (if enabled), RBQM (if enabled), eIQ Review (if enabled), Visualizations, and Data (including Data Stores and listings). 

To open the corresponding panels on the sheet within the workspace, select Subjects (if not already open), Queries, and Issues. Selecting Review Plan displays it over the left navigation. Alternatively, hover between Review Plan and the badges, and click the 3-dot icon to access the Review Plan Dashboard, Review Plan Panel, or Review Plan Details.

To expand the Protocol Deviations, RBQM, eIQ Review, Visualizations, and Data sections and make selections, use the side arrows next to each item.

To open the Records Review Summary panel, select the Open Records Review Summary icon (clipboard with checkmark) located to the right of Data.

Description of items on the workspace include:

Master Header 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 your defined landing page.
	Selected Study drop-down	Displays the current study in view. 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	Shows how many filters are applied, and opens the Filter Panel in the left navigation. The Filter Panel allows users to view applied filters in one area and access to Filter Sets, including Advanced Filters.
	Data Cuts icon	Click to apply an enabled Data Cut, and configure data cuts (Data Central Designer privilege needed to configure).
	Workspace drop-down	Shows the current workspace in view. Click the down arrow to view and select other workspaces. This includes previously saved private workspaces you created and public workspaces. When a study is first opened in Data Central, the pre-defined workspace for your role or the system Default workspace displays.
	Export icon	Click to export GPPs/Listing(s) in view.
	Notifications icon	Click to view and manage notifications for completed exports, such as patient profile workbook exports or GPP/Listings in view exports.
	Manage icon	Click to configure and manage folders used for workspaces, visualizations, and filter sets (user must have Data Central Designer privilege).
	Data Central Settings icon	Click to open the Data Central Settings window. The General Settings section has a checkbox to Use User Workspace, a drop-down menu to select the Number of visible rows in a table (the number of records displayed in each panel), and a checkbox to Use Default Filters. If permissions allow, the Data Central Settings, Workspace Defaults, and Configure Data Central Settings options are shown.
	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 [current version number].
	elluminate Assist icon (if enabled)	Click to open the GenAI-enabled text-to-SQL chatbot. It uses large language models (LLMs) to understand natural language questions related to SDTM safety data, generating results, relevant SQL queries, and explanations.
	Add Sheet icon (bottom left)	Click to add another sheet to the workspace. Many sheets can be added.
	All Sheets icon (bottom left)	Click to see a list of all sheets (including hidden sheets).
	Sheet name (bottom left)	The sheet in view is underlined in orange. Click another sheet to view. Click the 3 dots to rename, copy, delete, clear contents, or hide.

Study Metrics - Badges

In the left navigation, key study metrics are displayed 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) in the current view.
• Queries: Shows the count of answered queries (green) and open queries (red).
• Issues: Shows the count of answered issues (green) and open/in-progress issues (red).
• Review Plan: Displays the number of completed objectives (green) and those that are not started or in progress (red).

Badges Within Panels

Each panel, whether open or docked, displays a badge showing the number of currently available records. This number reflects any applied filters, whether default or user-defined.

Clicking the badge on any open or docked data or listing panel opens a drop-down menu showing the number of records displayed and any applied filters. 

Clicking a listing name opens a drop-down menu showing 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. It 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: The hyperlinked number in this column indicates the number of comments existing for the record. Click the number to open the Comments window to view existing comments and add a new comment.
• [Role] Records to Review: The hyperlinked number in this column indicates the number of records a role needs to review ('New' (not yet reviewed) plus 'Updated Since Reviewed' statuses). Click the number to open the Records Review Summary panel, filtered to show only Domains that contain that subject's records requiring review applicable to the user's role. 
• Open / In Progress and Answered Issues: These columns display hyperlinked numbers indicating the count of open / in-progress and answered issues, respectively. Click the number to open the Issues panel, filtered to show only issues with the selected status for that subject.
• Open and Answered Queries (if applicable): These columns display hyperlinked numbers indicating the count of open and answered queries, respectively. Click the number to open the Queries panel, filtered to show only queries with the selected status for that subject.
• Subject
• Site

Additional columns, such as Clean Status and other operations counts, are also available. The listing's columns are fully configurable to meet study-specific needs.

Actions and Features

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

• Open a record's Details view.
• Create an issue.
• Add annotations (annotation columns are located at the far right, if available).
• Configure or generate Workbook Patient Profiles (downloadable Excel file).
• Search for a column's name or label, and select it from the drop-down.
• View a Graphical Patient Profile.
• Use the Export icon to export the Subjects listing, with or without comments.
• Open Subjects Settings to hide columns, manage annotation columns, and manage column and row highlighting.
• 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 & Actionsbelow.

Apply an advanced filter that targets the domain used to configure the Subjects listing, as well as other relevant domains. 

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

Navigate Open Panels on a Sheet

Navigate between open panels (e.g., listings, graphical patient profiles, record details, visualizations) using the back arrow in any open (undocked) panel.

Records Review Summary Panel

The Records Review Summary panel shows review metrics for the logged in user and all users configured for the study. Users set up with a Data Central reviewer role will see two versions of the table, a 'My Role' view (default), and an 'All Roles' view. The 'My Role' view allows users to focus on their role and quickly identify the work they need to accomplish. The 'All Roles' view provides a summary of the review progress and remaining work for all roles. Both views will display the Domain Name, Domain Label, Data Store, and Total Records for each domain, the difference is in the review metrics displayed.

This panel can be accessed 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: The metric tiles will vary based on your Data Central reviewer role.

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

Click the switch icon to view the panel for all roles. 

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 that are not set up for review in a particular domain, a dash will be displayed.

All columns can be sorted and filtered.

Clicking on a Domain Name opens that domain listing.

Toolbar Icons & Actions

Panel toolbars contain icons representing available actions. Hovering over an icon displays a tooltip describing its function. Right-clicking a record also provides access to these actions via a pop-up menu.

Further details regarding the functionality of each icon are described in the sections where those icons are utilized.  

Icon	Icon Label	Action
	Previous / Next Page	Click to move to the previous or next page.
	Details	Click a highlighted record; a new window will open. This window shows Subject Detail fields, related issues, queries, and comments, as configured.
	Create Issue	Click to create an issue for the highlighted record.
	Workbook Patient Profile	Click to download a Workbook Patient Profile (WPP) for the highlighted subject. Users with the Study Configure privilege can also choose Configure to configure the WPP.
	Graphical Patient Profile	Click to open a Graphical Patient Profile (GPP) for the highlighted subject. Users with Study Configure privilege can also choose Configure to configure the GPP.
	Export	Click to download the panel or listing. All rows are included in the export, not just the rows that display. If any filters are applied, only the filtered results are exported. Depending on the panel or listing being exported, additional options may be available (i.e., domain listings can be exported for only my role, or all roles).
	Configure	Click to configure domain settings; available actions are determined by your system privileges).
	Filter	The Filter icon appears in several sheet areas: Listing badges: Indicates whether filters are applied to the panel's columns. Column headers: Indicates whether a filter is applied to that specific column.
	Action	Click to action queries or issues.
	Filter subject in other panels	Highlight a record in a panel and then click the icon to filter all other open panels for that highlighted subject; all other panels on the sheet update to show only the records for that subject. The panel in which the icon was clicked shows all records allowing the user to move to another record in that listing. When active, the icon is highlighted. Clicking the icon again removes the filter and all panels update to include all records.
	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 or restore a panel. When a panel is open or docked, click to maximize the panel. In a maximized panel, click the Restore icon to return the panel to the previous state of open or docked.
	Dock Item	Click to dock a panel or listing to the sheet.
	Create	Click to create an issue, add a comment, or create a query. Options are dependent on panel, domain, and data point, and whether the study is configured to use query processing.
	History	Click to view field history. For Query details, this shows the query history from the EDC (if available). For Data and Listing details, it shows the history of the highlighted field in the EDC.
	View Record in Rave EDC	Click to navigate to the associated record in Rave EDC (if a Rave study).
	Review / Review Operations	Click Review to mark a record(s) as reviewed and click the down arrow next to Review for more review options.
	Data Variance	Click to specify 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.
	Edit	In the Details view of an issue, click to edit the issue.
	Start Progress	Click to progress an open issue. (If configured for the URL.)
	Answer Query/Answer Issue	In the Details view of a query, click to answer the query (if study is configured for queries and the operation is supported by the EDC). In the Details view of an issue, click to answer the issue.
	Close Query / Close Issue	In the Details view of a query, click to close the query (if study is configured for queries and the operation is supported by the EDC). In the Details view of an issue, click to close the issue.
	Close as Irresolvable	In the Details view of an issue, click to close the issue as irresolvable. This is a sub status of a closed issue.
	Move Issue to Pending	In the Details view of an issue, click to move an issue to pending. This is a sub status of an open issue.
	Reopen Issue	Click to reopen a closed issue.
	Cancel Query / Cancel Issue	In the Details view of a query, click to close the query (if study is configured for queries and the operation is supported by the EDC). In the Details view of an issue, click to close the issue.
	Requery	In the Details view of a query, click to requery to the EDC (if study is configured for queries and this operation is supported by the EDC).
	Save	Click to Save.
	Save as...	When creating a new workspace, click Save as..., this opens the Configure Workspace window.
	Zoom Out	Within a Graphical Patient Profile (GPP), the profile opens in a zoomed-out state, if you move the timelines, click the Zoom Out icon to reset the profile.
	Alert	When this icon appears in a domain listing, it means that the domain has an improper key definition. Hover over the icon to read the message. When this appears in the first column within the details view of a record, it indicates that the field value has changed since it was last reviewed.
	Close	Click to close the panel (or remove from sheet).