Permissions: Users must have the Data Central and Study Configure privileges to configure a study in Data Central.

Before a study can be accessed within Data Central, it must be configured.

Types of Studies that Integrate with Data Central

• EDC Study with Two-way Query Information

  elluminate can pull in ODM data from the EDC systems, including query information. In addition to data review, for these studies Data Central supports management of the queries (Create, Answer, Close, Cancel, Requery) and provides the ability to communicate directly back to the EDC for any action taken on a query.
  
  Supported two-way EDCs: Rave, InForm, and Veeva.

• EDC Study with One-way Query Information

  The Data Central module can provide query information for users to review from studies from EDC systems whose query information can be mapped into the elluminate Queries table. However, Data Central does not currently support communication back to the EDC of query actions such as Create, Answer, and Close. 

• EDC Study with No Available Query Information

  For these types of studies, when using Data Central, the user will not see any reference to Queries, but will be able to perform full review of the data and raise and process issues.

Study Configuration Assumptions

Before configuring a Data Central study, assumptions are made about the study's elluminate configuration. Expand any of the items below for more details:

• Rave EDC Studies:

  • Rave is being developed by eClinical Solutions (preferred, but not mandatory)
  • Rave study exists and has data
  • Clinical data are available through Biostats Gateway
  • Operational data are available through ODM Adaptor
  • Incremental data loads are available (not mandatory)
    
    
  • Rave Data Sources
    • URL for Biostats Gateway and Rave ODM Adaptor imports
    • Rave username for Biostats Gateway and Rave ODM Adaptor access through RWS
    • Rave remote study name
    • Rave environment name
    • Current CRF version
      
      
  • Rave Access
    • An available RWS account (e.g., ECLIN_RWS1, etc.)
      • This account is for user access to Rave for processing queries, which must be done through an account that has Rave Web Services access; an iMedidata account will not work. The RWS account can be the same as the one used for Biostats Gateway and ODM Adaptor, but does not have to be.
      • The elluminate Audit Log contains the required data to track activity between elluminate and Rave.
    • Rave user name(s) and password(s)
      
      

• non-Rave EDC Studies:

  • The study exists and has clinical data
  • Operational data are available (not mandatory)
  • Query data, if available, have been mapped to Data Central internal requirements
  • Incremental data loads are available (not mandatory)

Configure Data Central Studies

From the Platform Menu, select Data Central Studies under Data Review. The Data Central landing page displays a study card for each study for which Data Central is enabled.

Studies that have not yet been configured for Data Central are identified with the red triangle next to the study name, and the study name is in black text and not a hyperlink. For these studies, click the red triangle, or the gear icon and select Data Central Configuration. This opens the Data Central Configuration window.

The study name for studies that are already configured for Data Central are in blue text and a hyperlink to the Data Central study landing page. 

To edit a configuration item of a study already configured, click the gear icon in the study card and select Data Central Configuration.

Overview

The first Configuration view is the Overview. This provides an overview of the status of all configurable items. As items are configured, the view of the Overview will change.

Upon initial configuration of Data Central, sections will have an alert icon indicating configuration is required. The sections can be accessed by clicking the hyperlinked item next to the alert icon, or from the left navigation. After a section has been configured a green checkmark displays next to the configuration item.

Assign Reviewer Roles

Users are assigned Reviewer Roles that dictate the actions they can perform in Data Central: Read Only, Data Manager, Medical Data Reviewer, and Medical Coder. By default, all users are set to Read Only.

Note: The ability to add additional roles is available. Your Project Manager can guide you through this process.

• Read Only (RO): Access all Data Central screens, but cannot mark data as reviewed or create and manage queries. To support collaboration, Read Only users can add comments and create issues. Users will automatically default to Read Only.
• Data Manager (DM): Full Data Central functionality, including the ability to mark data as reviewed and create and answer Rave EDC queries. For Rave studies, permissible query activity for each marking group is defined in the Role Configuration.
• Medical Coder (MC): Same scope of access and activity as DM, but permissible query actions are separately configurable for each marking group.
• Medical Data Reviewer (MDR): Same scope of access and activity as DM, but permissible query actions are separately configurable for each marking group.

Important: Remember that access to Data Central, as well as the ability to mark data as reviewed and process EDC queries, is controlled via privileges in User Management. All users with the Data Central privilege for an active study, including unlicensed users, will appear in the Reviewer Roles list.

Also, if Clean Participant Tracking is enabled, ensure that the appropriate roles are assigned.

The first time you access Reviewer Roles, or if a user has been added, a message briefly displays, showing the number of newly added users who may not have been configured, and whom action may be required.

1. Click Reviewer Roles. A listing displays with users assigned to the study. By default, users are initially assigned the Read Only role.
2. Check the box(es) at the left of the username(s) to be updated. 
3. Select the Role by clicking the associated radio button. Choose from Read Only (the default), Data Manager, Medical Coder, Medical Data Reviewer, or other custom roles (if added).
4. Check Receives Role Notifications to send email notifications to the selected user(s) when a role is assigned an action (query or issue). Alternatively, check the box in the Notifications column.
5. Click Save in the top right corner. A confirmation popup displays.

Important: If changes are made and not saved before moving to another configuration item, a warning displays. Click Cancel to remain on the page and save the changes, or click Continue and the changes to the Reviewer Roles are not saved.

Configure Subjects Listing

Use Subjects Listing settings to identify the data store and domain containing key subject information, the columns for the Subjects listing, and the fields for the Subject Details (single-record) window. For non-Rave studies, optionally identify a subject status field. Also, enable and configure the Subjects listing as a Clean Participant Tracker.

1. Click Subjects Listing in the left navigation (or the hyperlink in the Overview window).
2. Select the Domain from the drop-down list of available data stores and domains containing the subject information to be used by Data Central. For example, the DM (demographics) domain, a domain created in Mapper that includes fields from several domains, or a mapping specifically for the Clean Participant Tracker may be chosen.
3. Select the Subject Identifier Field (that uniquely identifies a subject) from the drop-down list of variables within the selected domain. 
4. Select the Site Identifier Field (that uniquely identifies a site) from the drop-down list of variables within the selected domain. 
5. Append Default Rave Status: If the domain selected does not include a Status field, this checkbox becomes available after Query Settings have been configured. If the Status field is included in the mapped Domain (selected in the Domain field), you may choose not to select the 'Append Default Rave Status' checkbox.
6. Select fields to display in Subjects Listing: These are the columns included in the Subjects listing. Search by typing; matching fields will appear. Select all or select fields individually. The following columns display by default, but additional columns can be added:
   • • [Reviewer Role] Records to Review
       • Reviewer Roles with >1 user assigned and >1 Data Review settings configured
     • Open / In Progress (if enabled) Issues
     • Answered Issues
     • Open Queries (displays for studies with query information imported from the EDC)
     • Answered Queries
     • Subject
     • Site
     • Status (When not a Rave study, and a Subject Status field has not been identified, this column will not display.)
7. Select fields to display in Subject Details: These are the fields included in the Subject Details (single-record view). Search by typing; matching fields will appear. Select all or select fields individually.
8. Toggle Enable Subjects Listing to include Clean Status to enable the Clean Participant Tracker. 
9. Select the Subject Status Field from the drop-down list to identify the subject's status. This field must be one of those selected for display in the Subjects Listing (Step 6). For Rave studies, the 'Append Default Rave Status' (Step 5) may be selected instead. A selected subject status field is required for Clean Participant Tracker visualizations to display properly.
10. Select the Group Assignment Field from the drop-down list to identify the cohort or group assignment. This field must be one of those selected for display in the Subjects Listing (Step 6). A selected group assignment field is required for Clean Participant Tracker visualizations to display properly.
11. System Fields: Select to include in calculation of Clean Status. 
    1. Queries and Issues: Select the query and issue statuses to include.
    2. Reviewer Roles: Select the reviewer roles to include.
12. Domain Fields: Select the numeric fields to be used in the calculation.
13. Click Save.

Configure Data Review Settings

Use Data Review Settings to specify which data stores will be available in Data Central, how the data will appear, and which domains are designated for data review. This can be assigned by role. Identify default Subject ID, Site ID, and Visit ID fields for each data store, any overrides for specific domains, and any hidden domains.

1. Click Data Review in the left navigation (or the hyperlink from the Overview window). The list of Data Stores displays below Data Review.
   
   
2. Select the Data Store for Related Forms from the drop-down list of data stores that contains the clinical data from the EDC source. 
   
3. Click the data store shown below Data Review in the left navigation to be configured for data review. For example, Clinical.
   
   
4. Default Identifiers tab
   1. Select the Subject ID from the drop-down, the field that contains the subject identifier within the domain.
   2. Select the Site ID from the drop-down, the field that contains the site identifier within the domain.
   3. Optionally, select the Visit ID from the drop-down, the field that contains the visit identifier within the domain. If selected, the Visit ID will automatically populate in the Create Issue window when creating an issue.
   4. Click the Validate Keys button to check / validate the key configuration (including the auto configuration for keys for Rave, TrialMaster, etc.) for each domain. A separate window opens with a listing of the domain(s) and warning message(s) if there are any non-unique key combinations for the defined keys. Warning messages are informational only, no corrective action is enforced. Warning messages may include:
      • One or more columns defined for this table are not present in the table. Missing key columns(s): defined key field entered such as USUBJID.
        • Keys do not produce unique results. The following values are duplicated: results are listed.
        • No keys defined.
        • If no validation errors are found for a data store, 'No validation errors found!' displays.
      • Click Close to close the Key Validation warning messages window.
5. Identifier Overrides tab
   
   
   1. Optionally, click the Identifier Overrides tab. Use Overrides to specify the site and subject identifiers for domains whose field names differ from the specified defaults; this would most likely apply to labs or other external data.
   2. Click the Add icon (the plus sign).
   3. Select the Domain from the drop-down list (from the selected Data Store).
   4. Select the SiteID from the drop-down list (from the selected Domain).
   5. Select the SubjectID from the drop-down list (from the selected Domain).
      
   6. Repeat for other domains as needed.
   7. To delete a row, check the box at the left of the row and click the Delete icon.
6. Review Settings tab
   
   

   
   Tip: Checking 'Enable Data Review' will automatically check 'Show Domains' if it was not already checked.
   Unchecking 'Show Domains' will automatically uncheck 'Enable Data Review' if it was previously checked.

   Note: When a domain previously enabled for review is disabled in Data Central, all review statuses, comments, linked issues, and annotations are preserved as they were at the time of disablement. If the domain is re-enabled, users will see this preserved context, reflecting the state at the time it was disabled. While the domain is disabled, review tracking does not continue. However, if the domain remains visible, users may still be able to add comments or annotations, even though formal review is not active.

   Important: If Clean Participant Tracking is enabled, ensure that each domain is enabled for data review for the appropriate data reviewer roles.

   1. For each role listed:
      1. Check Show Domains for the domains to display in Data Central.
      2. Check Enable Data Review to enable records to be marked as reviewed. If this is not checked, users can still view the data, but cannot mark records as reviewed. 
      3. Click the Domain Settings icon to open a separate window.
         
         
         1. New Domains are automatically Visible: check to automatically include added domains.
         2. New Domains automatically set to Review: check to automatically enable data review for added domains.
         3. Show Domains: Either check Select all for Show Domains, or check individually for each Domain.
         4. Enable Data Review: Either check Select all for Enable all domains for data review, or check individually for each domain.
         5. Click Apply (bottom right).
7. Repeat these steps for any of the other data stores that should be included in Data Review, such as Exception Listings.
8. Click Save (top right).

Note: No updates to Keys can be completed within Data Central, Data Review Settings. 

Configure Query Settings

Query Settings is only applicable for studies with query data. If the study does not have query data, skip this configuration item.

1. Click Query in the left navigation (or the hyperlink from the Overview window).
2. Select Show Queries in Data Central if the study has a query table and queries should be viewable in Data Central.
3. Select the Data Store for Queries Table from the drop-down list, the data store that holds the query table. For Rave studies, the required entry is ODM_Mapped. For studies from another EDC, the data store must not be ODM_Mapped. 
   Note: This data store must be the same data store that is selected for Enable Operational Analytics from the Settings tab when creating or editing a study in elluminate, and is only required when using CTOA.
4. Enter the number of Open Days, the number of days that a query is allowed to remain in the state of 'Open' before it is considered overdue.
5. Enter the number of Answer Days, the number of days that a query is allowed to remain in the state of 'Answered' before it is considered overdue.
6. Select the Data Source for query information, the import definition name for the Operational Data Source for the study.
   
7. Select Use Stored Credentials if the stored EDC (e.g., Rave or other EDC) credentials should be used when creating queries in Data Central; this would eliminate the need for the user to enter the EDC credentials themselves.
8. Select Append elluminate username to all query text to display the username within the query text. It will display as [username].

Assign Role Query Actions

Data Central supports two-way query processing between elluminate and the Rave, InForm, and Veeva EDC systems. Rave EDC queries are classified into notification groups that reflect the roles of the query originator and the recipient(s). For example, a query initiated by a Data Manager for site personnel to answer might be considered to be in the 'DM to Site' notification group.

Assign Role Query Actions in Rave

To support EDC query workflow in Data Central, Role Configuration is used to add the notification group and then to define the actions that a role can perform on queries of a given notification group in each query status (Open, Answered, Closed, Cancelled, or None).

Notification Groups can be imported to ensure accuracy in how the notification groups have been configured at the system level, or they can be added manually.

Important: Notification Groups added to Data Central must be exactly as they are defined in Rave. Without an exact match, query processing will not work. This refers to spacing and not case – either upper or lower case will work, but any extra spaces in the elluminate definition and not the Rave definition (or vice versa) will cause the query communication to fail.

Note: The default Data Central Configuration includes the notification groups that are part of the eCS standard Rave configuration, but these can be changed.

Add Notification Groups

1. Click Role Query Actions in the left navigation (or the hyperlink from the Overview window). A list of roles displays in both the left navigation and the window. 
2. Click a role (e.g., Data Manager (DM)).
   Notification groups can be imported or added manually. Using the import process ensures accuracy in how notification groups are configured at the system level.  
3. To import a notification group, click the Import System Notification Groups icon.  
4. Select the Notification Group(s) by checking the box next to each group to be added.
5. Click Import.
   The Notification Groups are added for that role.
   OR
6. To manually add a notification group, click the Add Notification Group icon (the plus sign).
7. Click in the Name field and enter the notification group, such as DM to MDR, or DM to Site. These must match the notification groups used by Rave.
8. Click outside of the Name field. Repeat this to add additional notification groups.
9. If there is more than one notification group for a role, select the Default by clicking the radio button of the notification group.
10. Repeat adding Notification Groups for each role.

Delete a Notification Group

1. Click Role Query Actions in the left navigation (or the hyperlink from the Overview window). A list of roles displays in both the left navigation and the window. 
2. Click a role (e.g., Data Manager (DM). The list of Notification Groups displays.
3. Select the Notification Group to delete.
4. Click the Delete Notification Group icon (the trashcan).
5. A confirmation popup displays. Click OK to confirm.

Assign Query Actions to Notification Groups

After the Notification Groups have been added to a role, the actions that role can take on a query must be defined. This process is the same regardless of whether the notification group was imported or added manually.

1. Select a Notification Group from the list of Notification Groups. For example, DM to Site.
   All the query statuses (Open, Answered, Closed, Cancelled, and None) display down the left side and the possible actions display across the top. Place a checkmark in the status box to define the actions that users with this role can perform.

   Note: Checking the Open box for the None status allows that role to open new queries for that notification group.

2. Use the arrow to minimize the Status/Actions selections.
3. Return to step 1 and assign query actions for other notification groups, as appropriate.
4. Click the Save button at the top right when finished.

Assign Role Query Actions for InForm or Veeva Studies

Role Query Actions are configured for each role listed in the left navigation. The Actions table lists the statuses in the left column and actions in the columns to the right.

1. Click a role in the left navigation (e.g., Data Manager (DM). 
2. For each Status listed in the left column, place a checkmark in the box to define the actions that users with this role can perform.
   

   Note: Statuses and actions may differ between InForm and Veeva studies. For example, actions for Veeva studies include Open, Answer, Close and InForm studies include Open, Answer, Close, Cancel, and Reopen.

3. Continue defining each role listed in the left navigation.

Configure Key Fields for a Data Central Study

Data Central must be able to uniquely identify each record in a domain to maintain the information it stores about those records. This information includes the review status, comments, annotations, and issues.

Note: When data is imported from RAVE, or other recognized EDC systems, the record ID used in the EDC is automatically used as a key field. No additional configuration is needed for domains imported from the EDC.

elluminate uses this Key field to uniquely identify the records in a given domain.

For other data, including mapped data, this key field should be identified to maintain the link between the original records and any Data Central associated information (review status, comments, annotations, issues). If Key fields are not identified, the system will be unable to track review statuses between imports / mappings if data in the underlying record changes.

Important: Without Key fields, any comments, issues, or annotations made for a record will be lost if the data, or data structure changes.

Key Study Variables

The study configuration's ETL tab allows manual specification of common Key Study Variables for the data stores.

Each Data Store is listed with a Key field, Overrides button, and Validate button.

Key Variables and Mapped Data

For domains that are created by the Mapper, it is important to note that the key fields must be maintained between mappings. If a record ID field is added as part of the mapping process, it is critical that a record will always have the same record ID, even if the data changes.

For example, a joined table created by the mapper might benefit from a concatenated field of the original record IDs from the joined domains to ensure consistency.

Key fields must be identified after a mapping has been executed and the data is available in the target data store identified in the mapping.

Define Key Columns

Defining the key columns is critical to allow the system to track unique records between imports. This is important for the Data Variance feature to work as expected.

To configure Key Columns for the domains in a data store:

1. Click the Studies Home page and click the Edit icon for a study.
2. Click the ETL tab.
   
3. In the Keys field, enter the key field(s), or a comma separated list of key fields that apply to records in the domains in that data store.
4. If a Domain in the data store has different key columns than those identified in step 3, click the gear icon in the Overrides column. A Domain Specific Keys window opens.
5. In the Domain field, enter the domain name for the key. For keys used in multiple domains, enter a comma-separated list of domain names.
6. In the Keys field, enter a comma separated list of fields that can uniquely identify the records in the domain. Common key fields will depend on the table structure but often include a recordID, or a combination of Subject ID, Visit details, or date fields.
7. Click the plus sign and repeat steps 5 and 6 for each domain that has a different key.
8. Click the plus sign to add a blank row to ensure the last entry was saved.
9. Click Save. The Domain Specific Keys window closes.
10. For each data store, click the Validate icon to check / validate the key configuration (including the auto configuration for keys for Rave, TrialMaster, etc.) for each domain. A separate window opens with a listing of the domain(s) and warning message(s) if there are any non-unique key combinations for the defined keys. Warning messages are informational only, no corrective action is enforced. Warning messages may include:
    • One or more columns defined for this table are not present in the table. Missing key columns(s): defined key field entered such as USUBJID.
    • Keys do not produce unique results. The following values are duplicated: results are listed.
    • No keys defined.
    • If no validation errors are found for a data store, 'No validation errors found!' displays.
11. Click X to close the Key Validation warning messages window.
    
    The screenshot below displays an example of using the Validate button for the Clinical data store.