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 RBQM, eIQ Review, Protocol Deviations, and Clean Progress Tracking are configured and viewed within 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:

• 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, access it under Study Management in the Platform menu or from the Details drop-down in 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 at the right of Data Central under Study Management.

Access a Data Central Study from the Studies Details View

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

1. Click the Study Name from the Studies Home Page.
2. Click the Details drop-down 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 Home Page (or your configured Home Page).
• Data Central Studies (blue badge): Indicates you are on the Data Central Studies page; the blue badge shows 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 your favorite studies. Click the Star icon on a study card to add a study to your favorites; click again to show all studies.
• Quick Filters icon: Click the drop-down to filter 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 the drop-down menu to access the Help Center, Community, Learning Portal, Support, Privacy Policy, Legal Notices, or About [current version number].

B. A Study Card configured for Data Central.

C. A Study Card not yet 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 icon (plus sign). 
4. Enter the New Custom Group name and click the checkmark.
5. Next to the Group Name, click the Add Subgroup icon (plus sign).
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 '36/964 Answered Issues,' indicating 36 of 96 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. 
    
• 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.
    • 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 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 users can customize.

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 displays when you first open Data Central. Depending on the configuration, you may see either the system default workspace or a role-specific workspace. The user’s workspace is assigned during the configuration of the study in Data Central.

Left Navigation

Items on the left navigation include panels: Subjects, Queries (if integrated with an EDC, such as Medidata Rave, Veeva, or InForm that provide query information), Issues, Protocol Deviations (if enabled), RBQM (if enabled), eIQ Review (if enabled), Visualizations, and Data (Data Stores and listings). 

Click Subjects (if not already open), Queries, and Issues to open those panels on the sheet within the workspace.

Click the side arrows next to Protocol Deviations, RBQM, eIQ Review, Visualizations, and Data to expand those sections and make selections.

Click the Open Records Review Summary icon (clipboard with checkmark) to the right of Data to open the Records Review Summary panel.

Description of items on the workspace include:

Study Metrics - Badges

In the left navigation, key study metrics are displayed as badges next to Subjects, Queries, and Issues:

• Subjects: Badges indicate the total number of subjects (blue) and the number of filtered subjects (orange) in the current view.
• Queries: Badges show the count of answered (green) and open (red) queries.
• Issues: Badges show the count of answered (green) and open/in-progress (red) issues.

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).
• 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 Work with Toolbars below.

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.

Work with Toolbars

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.