Permissions: Users must have the Study Configure privilege to configure the Reporting Database.

The elluminate Reporting Database is an external database hosted in Amazon Web Services Relational Database Service (AWS RDS) or Snowflake, which mirrors and replicates selected data stores from elluminate. Unlike the existing Reporting Data Mart, which is an internal data store for mapped study data, the Reporting Database exists independently, outside of elluminate. Users can securely connect to the Reporting Database for ad hoc queries, analytical dashboard creation, and broader analytical functions, all without impacting production data in elluminate. 

This feature enables users to replicate their elluminate data into an external database environment. This provides a flexible and secure solution for data analysis and reporting. By using the Reporting Database, users can maintain data integrity and security while accessing their data in new ways.

Here is how it works:

1. Establish Connection: A connection is set up between elluminate and an external database (Snowflake or AWS RDS), allowing elluminate to interact with the external database system.
2. Configure Data Stores: Data stores for a study are selected for the data to be pushed to the external database.
3. Schema Replication: All configured data stores, including their domains, are replicated into the external database. This maintains the same database schemas and structures found in elluminate.
4. Data Replication: The Reporting Database replicates the data contents of the configured data stores into the target Snowflake or AWS RDS instance. 
5. Assign User Privileges: The administrator assigns users access to the Reporting Database, either by individually assigning the 'Reporting DB' privilege or by assigning access to specific groups.

Benefits for Users:

• Data Availability: Users gain access to a regularly updated copy of their data, separate from the elluminate database, for analysis and querying.
• Sponsor-Specific Needs: The external database can be customized and tailored to meet specific sponsor requirements.
• Enhanced Access and Control: Users can utilize their existing elluminate user account data access privileges and permissions to log in and access data on the Reporting Database, providing a secure and controlled environment.

Configure the Reporting Database for a Study

1. Navigate to the New / Edit Study > ETL tab.

   

2. Select the data stores:
   1. Enable all current and future data stores: Includes all current data stores, including ODM Mapped, and their domains. Any future data stores and domains are automatically added to the Reporting Database during refreshes. 
   2. Enable ODM Mapped Data Store: Includes the ODM Mapped Data Store without requiring inclusion of all current and future data stores for the study. This option is useful for incorporating data imported from EDC systems, such as queries, audit trail information, and other operational data. All domains within the ODM Mapped Data Store are pushed to the Reporting Database during refreshes. This option can be selected in addition to individual data stores from the Key Study Variables table.
   3. Individual data store selection: Allows manual selection of specific data stores from the Key Study Variables table. All domains within the selected data stores are pushed to the Reporting Database during refreshes. 
      • Select the checkbox in the table header to include all listed data stores, or select individual data stores by checking their corresponding boxes.
3. Click Save.

Note: After the Reporting Database is configured, changes to data stores, such as adding or removing domains, are reflected in the external database during the next refresh cycle.

User Configuration

The eCS managed Reporting Database tenant allows for user access to the connected Snowflake or AWS RDS instance to be configured based on existing elluminate user configurations. Users assigned the 'Reporting Database' system privilege will automatically have their elluminate data access privileges (including study access, denied data stores, and blinding) copied to the Reporting Database.

A Reporting Database username is required for saving users with this privilege. Users can manage their Reporting Database password within their elluminate user profiles. 

Enable Reporting Database for a User / User Group

1. Within User Management, navigate to Edit User or Edit Group > Privileges.
2. From the list of privileges, select Reporting DB.
   
3. Click Save.

Important: When the Reporting DB privilege is assigned to a User Group, each user in the group must have a Reporting Database username added to their credentials.

Create a Reporting Database Username

1. Within User Management, navigate to Edit User > Credentials (for a user granted the Reporting Database system privilege).
2. Enter the Reporting DB Username. This username will display in the 'My Profile' window for the user, and must match to the connected external database.
   
3. Click Save.

Manage the Reporting Database User Password

During a user's first login to the Reporting Database, they will need to create a password within their User Profile. Passwords can also be changed as needed in their User Profile.

Note: Creating and editing the Reporting Database password is only applicable for eCS managed instances of AWS RDS or Snowflake systems. This option will not be visible for configurations using externally managed databases.

1. Access your User Profile.
   
2. In the Reporting DB Credentials section, click Change next to Reporting DB Password.
   
3. Enter in New Password.
4. Enter in Confirm Password.
5. Click Save to close the Change Reporting DB Password window.
6. Click Save to close the My Profile window.

Create Snowflake or AWS RDS Account

Important: The Snowflake or AWS RDS Account must have the SAME username as the Reporting Database username.

Once a user is established with a Reporting Database account in elluminate, their credentials are managed in elluminate, and their access privileges are automatically updated in the Reporting Database. 

However, because the external Snowflake or AWS RDS instance is not within the eCS network, credentials cannot be directly transferred. Users must create their own accounts in Snowflake or AWS RDS, following sponsor protocols, and using the same Reporting Database username created for them.

Once this is complete, the Reporting Database can enforce user data access restrictions similar to an eCS managed Snowflake or AWS RDS instance.