Tip: eClinical Solutions recommends configuring study attributes in elluminate before creating a study to streamline future setup processes.

elluminate allows users to define various clinical study attributes using drop-down lists configured within the elluminate configuration. While many options are standardized and pre-loaded, users can also add custom configuration items as needed. Incorporating these study configuration elements enhances the reporting and analysis capabilities within elluminate.

Configuration Items

• Therapeutic Areas
• Compounds (This configuration item is required when creating a new study.)
• Programs
• Phases
• Study Types 
• Endpoints
• Controls
• Blindings
• Staging Areas
• Data Marts
• Notification Groups
• Tags
• Roles
• Query Categories
• Companies
• Issue Priority
• Review Objective Priority

Tip: In addition to manually adding configuration items, details can be imported from existing elluminate environments to accelerate the setup process.

Add Configuration Item

These steps illustrate the example process of adding a new Therapeutic Area (TA), but the same approach applies to most configuration types.

Note: See the sections below for more details on:  Add Staging Areas and Data Marts,  View Existing Tags, Customize Issue Priorities, and Customize Review Objective Priorities.                       

1. Click the 9-dot icon to open the Platform Menu.
2. From the left side of the menu, click Configuration under Platform Administration.
   
3. The system Configuration window opens. Configuration options are displayed in the left panel, and corresponding configuration details appear on the right.  
4. Therapeutic Areas (TAs) opens by default, displaying a predefined list of common TAs. Optionally, select a different configuration option from the left panel.
   
5. Click the plus sign in the master header. The Add Configuration Item window opens.
6. Enter a Name for the configuration item. This is a required item, indicated by the red asterisk (*).

7. Enter a Description for the configuration item. This optional field provides additional information about the item and may help users identify the correct selection.

   Note: Available fields vary depending on the configuration type and elluminate version. For example, Roles include an Abbreviation field and, beginning in version 25.2, an optional Description field. Data Advisor uses role descriptions to provide context-aware insights, recommendations, and guidance. Study Type includes an Applies To field.

8. Complete all fields as appropriate for the selected configuration type.
9. Click Save to add the item.
10. Repeat these steps for all configuration items needed for studies within this elluminate instance. If the necessary selections already exist, there is no need to re-enter them.

Add Staging Areas and Data Marts

In elluminate, study data is stored in a Data Store. Data Stores are made up of Staging Areas and Data Marts, which provide logical ways to store and organize data.

Staging Areas store source, or raw, data that is imported. By default, the Clinical and Operational Staging Areas are available. When data is imported using the Rave ODM Adapter, an ODM_Stage Staging Area is created automatically. Additional staging areas can be created to meet study requirements.

Data Marts store mapped data for reporting and analysis. By default, the Reporting and SDTM Data Marts are available. An ODM_Mapped Data Mart is created automatically when data is mapped from ODM_Stage. Additional data marts can be created to meet study requirements.

When a new elluminate site is set up, a default set of staging areas and data marts is pre-configured.  Refer to the Default Data Stores table below for details.

Use the steps below to create a new Staging Area or Data Mart. This example demonstrates creating a staging area; the same steps apply when creating a data mart.

1. Select Staging Areas in the left navigation.
2. Click the plus sign in the master header. The Add Staging Area window opens.
   
3. Enter a Name for the configuration item. This is a required item, indicated by the red asterisk (*).
4. Enter a Description for the configuration item. This is optional but may help ensure correct selection.
5. Optionally, enter a Schema Suffix. The schema suffix is used as part of the schema name in the elluminate database.
   By default, the schema name for each data store consists of a schema prefix (the study name) and a schema suffix (the data store name). For example, a data store called 'Source' in a study called 'Study1' would have a schema name of Study1_Source. Normally, there is no need to change the schema suffix.

6. Select the Default checkbox to designate this as the default Staging Area. This selection does not restrict access to other Staging Areas; it simply identifies the most frequently used one.

   Important: Changing the default Staging Area is a system-wide modification and is not limited to a specific study. Carefully evaluate this action before applying the change.
   The ability to set a default Staging Area is restricted to users with Admin or System Configure privileges. This applies to both new studies and studies being edited.

7. Click Save.

Default Data Stores

View Existing Tags

In elluminate, Tags can be used to group various domains across different data stores for the purpose of exporting data.

Tags are defined as a global configuration item and can be associated with domains through the Metadata module and / or Dynamic Mapping Templates.

1. Select Tags from the left navigation. The list of existing tags displays, showing the name, description, domain count, modified date, and the user who last modified each tag.
2. To create new tags, follow the instructions in Add Configuration Item.

Note: Tags can be used for exporting data and can be associated with domains via Dynamic Mapping Templates or the Metadata module.

Customize Issue Priorities

The standard set of priorities are available by default. Users can create new customized priorities and update attributes. Names within the standard set of priorities cannot be changed. 

Add a Custom Priority

1. Select Issue Priority from the left navigation.
2. Click the plus sign in the master header. The Add Issue Priority window opens.
   
3. Enter the Name of the priority (required).
4. Enter an optional Description.
5. Enter the Due in Days value, the number of days until the issue is due (required). This value is used to calculate the Due By date.
6. Select the Exclude Saturdays and / or Exclude Sundays checkboxes to exclude either or both weekend days from the due date calculation.
7. Select the Priority Color from the drop-down. This color highlights the priority field in the listing, or leave it blank for no highlight.
8. Select the Default checkbox to set this priority as the default when an issue is created.
9. Select the Active checkbox to include this priority in the drop-down when creating or editing an issue. 

Edit Issue Priorities

1. Select Issue Priority from the left navigation.
2. Click the row of the priority to be updated. Either click the Edit icon in the master header or double-click the row to open the edit window.
3. The Edit Issue Priority window opens.
   
4. Update the fields. The Name field for priorities in the standard set cannot be changed. 
5. Click Save.

Customize Review Objective Priorities

Active Review Objective Priorities are available in the Priority drop-down within the Add and Edit Review Objective windows. These priorities are used in the Integrated Data Review Plan (IDRP) feature of Data Central.

By default, Review Objective Priorities are ranked from 1 to 3: High (red), Medium (orange), and Low (yellow). These default priorities can be edited by modifying the color, description, and rank; however, the name cannot be changed. Additional custom priorities can be added to the list, and all priorities can be marked as active or inactive.

Edit a Review Objective Priority

1. Select Review Objective Priority from the left navigation.
2. Click the row of the review objective priority to be updated. Either click the Edit icon in the master header or double-click the row to open the edit window.
3. The Edit Review Objectives Priority window opens.
   
4. Update the fields accordingly. The Name of system-created priorities cannot be updated. 
5. Click Save.

Add a Custom Review Objective Priority

In addition to default priorities, custom Review Objective Priorities can be added.

1. From the list of priorities, click the plus sign in the master header.
2. Enter the Name of the Review Objective Priority (required).
3. Enter a Description.
4. Enter a Rank (required).
5. Select the Priority Color from the drop-down.
6. By default, Active is checked. Uncheck this option to mark the priority as inactive.
7. Click Save.

Delete a Review Objective Priority

System-created priorities cannot be deleted; however, custom priorities that are not in use can be deleted. 

Note: At least one Review Objective Priority (default or custom) must be active. A system message stating 'There must be at least 1 active priority' displays when no active priorities remain.

1. Select Review Objective Priority from the left navigation.
2. Click the row of the priority to be deleted.
3. Click the Delete icon in the master header.
4. In the Delete Review Objective Priority confirmation window, select Yes to delete or No to cancel the action.

Best Practices for Configuring Study Attributes

• Configure study attributes before creating the first study. At a minimum, set up essential items such as Compound (required), Therapeutic Area, Program, and other relevant attributes. Properly configuring these attributes ensures complete drop-down options during the Add Study and Edit Study processes.
• Standardize attribute vocabularies. Follow industry-standard practice by establishing a single approved list of values for items such as Therapeutic Area, Compounds, Program, Phase, Study Type, Blindings, Staging Areas, Data Marts, and more. Use consistent names and precise descriptions to prevent duplicates, improve search, simplify reporting, analytics, and governance across studies.
• Plan Data Stores intentionally. Use the default staging areas Clinical, Operational, and ODM_Stage for raw source data and the default data marts SDTM, Reporting, and ODM_Mapped for mapped analysis-ready outputs. Add new staging areas or data marts only when justified by integration or reporting needs. Set a default only when it should be the standard selection across the entire environment, as changes to default configurations affect all studies. Avoid altering the schema suffix, as it controls database schema names and can disrupt downstream processes like existing mappings; change it only if absolutely necessary. Document the modification thoroughly, and ensure all downstream programming and configuration function as expected after the change.
• Set priorities for review workflows. Configure the Issue Priority with Due in Days values to match the review turnaround times. Set the Review Objective Priority with numeric ranks to organize review work by risk and impact. This helps ensure timely follow-up across IDRP and issue management. If IDRP is in use in the environment, keep at least one Review Objective Priority active, try to standardize names and colors, limit the list to three to five levels, and review the settings regularly.
• Reuse proven configurations. When a configuration is confirmed to work as intended, export the configuration items to an Excel (.xlsx) file and then import the file into another elluminate environment to establish the same settings. Maintain a version-controlled library of approved exports, organized by environment and program, to speed up setup, reduce errors, and improve consistency across studies.