Tip: eClinical Solutions recommends configuring your study attributes in elluminate before creating the first study to streamline all future setups.

elluminate enables users to define various clinical study attributes through drop-down lists set in the elluminate configuration. Many options are standardized and pre-loaded in elluminate, but you can also add custom configuration items whenever needed. Incorporating the study configuration elements into your study allows for better reporting and analysis of the data 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

Tip: In addition to manually adding configuration items, you can also import configuration details from existing elluminate environments.

Add Configuration Item

These steps walk through the example process of adding a new Therapeutic Area (TA), but you will follow the same steps for most configuration types.

Note: Steps are slightly different for adding Staging Areas and Data Marts.

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 in the panel at the left and configuration details appear on the right.  
4. Therapeutic Areas (TAs) opens as the default, which includes a predefined list of common TAs. Optionally, click another configuration option in the panel at the left.
   
5. Click the plus sign at the top right of the window. The Add Configuration item window opens.
6. Enter a Name for the configuration item. This is a required item, as noted by the red asterisk at the end of the field.
7. Enter a Description for the configuration item. This is not required, but may be helpful in making the correct selection.
   

   Note: Depending on the configuration type, there may be different fields. For example, Roles and Companies, have an Abbreviation field. Study Type has an Applies To field. 

8. Continue to enter into each field as appropriate.
9. Click Save.
10. Repeat these steps for the other configuration items until all the information is entered for your study. If the selections you need have been previously entered, you do not need to enter them again.

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 your data.

Staging Areas hold the source, or raw, data that have been imported. By default, the Staging Areas of Clinical and Operational are available. If you import data from Rave ODM Adapter, an ODM_Stage staging area is automatically created. Additional staging areas may be created to meet your study’s needs.

Data Marts hold mapped data, which can then be used for reporting and analysis. By default, the Data Marts of Reporting and SDTM are available. An ODM_Mapped data mart is automatically created when data are mapped from ODM_Stage. Additional data marts may be created to meet your study's needs. 

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

Use the steps below to create a new Staging Area and Data Mart. This example walks you through creating a new Staging Area, but the steps are the same for adding a new Data Mart.

1. Click Staging Areas in the left navigation.
2. Click the plus sign at the top right of the window.
3. The Add Staging Area window opens.
   
4. Enter a Name for the configuration item. This is a required item, as noted by the asterisk at the end of the field name.
5. Enter a Description for the configuration item. This is not required, but can be helpful in making the correct selection.

6. 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.

7. Click in the Default checkbox if you want this to be the default Staging Area. By selecting this, you are not limiting yourself to only this Staging Area, you are simply selecting it as the one you use most frequently.
   

   Important: A change to the default Staging Area is a system change; it is not limited to a specific study. Please be very thoughtful before setting a new default.
   The ability to set a Staging Area as a default is limited to users with Admin or System Configure privileges. This is true for new studies or ones that you are editing.

8. Click Save.

Default Data Stores

View Existing Tags

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

Tags are defined as a global configuration item, and can then be associated to domains through the use of the metadata, and / or Dynamic Mapping Templates.

1. Click Tags in the left navigation. The list of existing tags displays. This listing displays the name, description, domain count, modified date, and modified by (user).
2. To create new tags, follow the instructions Add Configuration Item.

Note: Tags can be used for exporting data, and can be associated to 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. Click Issue Priority in the left navigation.
2. Click the plus sign at the top right of the window.
3. The Add Issue Priority window opens.
   
4. Name: Enter the name of the priority.
5. Description: Enter an optional description.
6. Due in Days: Enter the number of due in days. The number entered here will be used to calculate the Due By date.
7. Exclude Saturdays / Exclude Sundays: check to exclude weekend days.
8. Priority Color: Click the drop-down to select the color that highlights the priority field in the listing, or leave blank for no highlight.
9. Default: check this box to make this priority the default when an issue is created.
10. Active: check this box to include this priority in the drop-down when creating / editing an issue. 

Edit Issue Priorities

1. Click Issue Priority in the left navigation.
2. Click in the row of the priority you wish to update.
3. Click the Edit icon at the top right of the window.
4. The Edit Issue Priority window opens.
   
5. Update the fields. The Name field for priorities in the standard set cannot be changed. 
6. Click Save.