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

Data Central Designer: Allows the user 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 the user 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 users of Data Central.

Data Central provides a single, integrated platform for reviewing and managing all the data associated with a study, 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, for the purposes of data review, cleaning, and producing a high-quality database in near real time.  

Studies enabled for RBQM and eIQ Review 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.

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 the user with a dynamic workspace experience through easy navigation and efficient ways to group related data for more comprehensive review. Functional capabilities include:

• Predefined and customizable workspaces to support common review tasks
• Multiple search and filtering options that support review of individual listings or across multiple listings
• Ability to sort listings by multiple columns
• Ability to fix one or more columns as stationary while scrolling horizontally
• Annotation feature for adding inline observations, flagging protocol deviations based on review, etc.
• Using the Highlights feature to highlight cells and rows, as well as column headers.
• Ability to mark an entire domain or listing 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

The Data Central Studies Page can be accessed from the Platform Menu. Data Central for a specific study can be accessed from the Platform menu under Study Management, 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 on 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 is to use 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 on 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 on the Study Name from the Studies Home Page.
2. Click on 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 access the Platform Menu. 
• elluminate logomark: Click to return to the Studies Home Page.
• Data Central Studies with blue badge: Indicates you are on the Data Central Studies Home Page with the number of studies in the blue badge.
• Search: By default, the search by is Name. Click the drop-down to select by Description, Therapeutic Area, Compound, Phase, Type, or Program. Enter text in the Search field and click the magnifying glass. All studies with that text display and the number in the blue badge updates.
• Configuration: Click and select Study Group Configuration. See Configure Study Groups for details.
• Favorite: Click to view studies that you marked as favorite. To mark a study as your favorite, click the Star icon in the study card. The icon is shaded blue when only favorites are displayed. Click the icon again to display all studies.
• Enablement Focus: Click to select from the drop-down and filter by Data Central Configured, RBQM Enabled, ODR Enabled, Clinical Analytics Enabled, Operational Analytics Enabled, or Custom Analytics Enabled. Select Clear to display all Data Central studies.
• Groups: Click and select the group, then the subgroup name. Only studies added to the subgroup in Study Group Configuration display on your workspace. Click the icon again and select a different group / subgroup, or Clear to see all studies.
• Card View: This is the view by default; therefore, it is shaded blue. 
• Grid View: Click to view in Grid View. Studies are listed with the same details as the card view. Common elluminate listing functionality is available: Click on a column header to sort ascending or descending; or right-click to select the sort order, or fix / unfix a column to the right, or to the left.
  • Study Details: From the Grid View, click on a study row and click to open Study Details. 
  • Expanded View: From the Grid View, click on a study row and click to expand the view of that study.
• Help icon: Click to select from the drop-down options: Help Center, Community, Learning Portal, Support, Privacy Policy, Legal Notices, or About current version number.

B. A Study Card that is not yet configured for Data Central.

C. A Study Card that is 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. From 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 (the plus sign). 
4. Enter the Group name and click the checkmark.
5. Click the Add Subgroup icon (the plus sign) next to the Group Name.
6. Enter the 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. From 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 you wish to edit.
4. Click the Edit icon.
5. Make changes.
6. Click Save. 

Delete a Study Group or Subgroup

1. From 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 you wish 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. Therefore, if a user has different roles for the studies they have access to, the indicators will be different. The indicators displayed can be customized.

Metric tiles display as n of x. For example, in study Clintek-010 in the below screenshot display 6/212 Answered Issues; that is 6 issues have been answered from a total of 212 issues. The progress bar shows the work completed vs remaining. 

In addition to standard metrics, custom metrics can be configured and available to display. For example, Uncoded AEs and CMs. 

If a study is set up for using the Operational Data Repository, and data are available, the study card will include the latest and next milestone metrics. 

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

Tip: By default, 8 tiles display on a study card. Click the dots or arrows at the bottom of the study card to see more tiles.

Study cards display the following:

• Study Name
  • Studies not yet configured in Data Central display the red triangle icon. Click the red triangle to access the Data Central Configure window, or click the Configuration icon and select Data Central Configuration.
  • Studies configured for Data Central are in blue text. Click the hyperlinked study name to open the study in Data Central. 
• Icons at the top right
  • Study Details: Click to access the Study Details window.
  • Expanded View: Click to expand the view. 
    • From the expanded view you can click on a tile to open the associated listing in a separate tab.
    • From the expanded view, for studies that are Operational Data Repository enabled and have milestone data, view the study timeline.
  • Configuration: Click to select from the drop-down, Study Card Configuration, or Data Central Configuration. 
    • Study Card Configuration: The default set of indicators are selected. To update your study card view, see Configure Study Card below.
    • Data Central Configuration: Click to access the Data Central Configuration window.
  • Favorite: Click to mark a study as a favorite. Then use the Favorite top level icon to view only studies marked as favorites. 
• Number of Sites and Subjects: Under the study name view how many sites and subjects are 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 on a metric tile of a study configured for Data Central to open the associated listing in a separate 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 on the RBQM Direct Link to access the RBQM Overview dashboard.

Data Central opens for the selected study displaying the default workspace. A custom default workspace can be configured, however, if no workspace is configured, the 'Default' workspace displays, usually the Subjects listing (this is configurable per URL by a user with system configuration privileges).

Configure Study Card

The default set of indicators are selected. Users can customize their view of indicators on a study card.

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 or deselect the indicators you wish to see on that study card. Use the scrollbar at the right to see all indicators. The first eight metric tiles display on a card, to see additional tiles selected, click the dots or arrows at the bottom of the study card.
4. Use the 6 dots at the right of an indicator to reorder the metric tiles.
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 study is Protocol Deviations enabled), RBQM (if study is RBQM enabled), eIQ Review (if study is eIQ Review enabled), Visualizations, and Data (Data Stores and listings). 

Click on 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, numbers display next to Subjects, Queries, and Issues as badges to identify key metrics for your study:

• Subjects: The badges identify the total number of subjects in the study (blue) and number of filtered subjects (orange) in the current view.
• Queries: The badges identify the total number of answered queries (green) and number of open queries (red).
• Issues: The badges identify the total number of answered issues (green) and number of open issues (red).

Badges Within Panels

Each panel, open or docked, shows a badge indicating the number of records currently available. The number reflects any filtering that has been applied to the panel, whether by default or by user selection.

Clicking the badge on an open or docked data or listing domain will open a drop-down displaying the number of records being viewed, and if there are any applied filters. 

Clicking on the name of a listing will open a drop-down displaying domain 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 the Subjects listing as configured for the study.

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

The Subjects listing displays the following default columns:

• Metrics for Open and Answered Issues and Queries (if applicable)
• Site
• Subject
• DM Review Pending

Additional columns, such as Status for tracking subject status, are also available. The Subjects listing is configurable to meet study requirements.

Use the panel toolbar or right-click to select a subject, view subject details, view comments, create an issue, add annotations if annotations columns are available, view a Graphical Patient Profile, and generate a Patient Profile Workbook to be downloaded locally and viewed within Excel. For details on how to use each icon within the panel toolbar, see the Work with Toolbars section below.

Note: Use the scrollbar at the bottom of the panel to see all columns in the listing, use the filter and sort options as well as the fix columns left and right to customize your view of the panel.

Navigate Open Panels on a Sheet

Use the back arrow on any open (not docked) panel on a sheet to return to other open panels. Open panels can include any listing, graphical patient profile, record details, or visualization.

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. 

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

Each panel has a toolbar with icons that represent actions available in the panel. Toolbars are specific to each panel. Hovering over each icon in the toolbar provides a label indicating its function. Also, right-clicking on a record within the panel provides a pop-up window with the same toolbar options.

More details for using each icon are explained in the sections where the icons are used.