Configure and Manage Data Sources

Oracle Health Sciences InForm Discrepancy InForm Queries can be imported into elluminate and supports 2-way query integration. Name and Description: Confirm they have been entered appropriately. Address/URL: Enter the entire URL from which the data will be imported. Username: Enter the username that will be used to access the remote system. Password: Enter the password that will be used to access the remote system. Tenant Prefix: Enter the name of the tenant prefix. Remote Study: Enter the name of the study to access the source system.

Use Data Sources to specify the location and connection details for accessing the source data to be imported into elluminate, as well as its target location within the elluminate platform.

Data Sources can be added at the system, study, or global data store level. If a data source is added at the study or global data store level, it can later be promoted to a system data source.

Before a data source can be imported for the first time, the data store itself needs to be defined. This means providing information about the import type and the specific details related to that type of data source.

If a data source has not yet been defined, no data sources will be listed. As many data sources as necessary can be created to align with the data that needs to be imported.

Users with the Importer privilege can choose from system, study, or global data store data sources when creating an import definition. Any changes made to fields within a data source will only affect that particular import definition.

Important: Data Source Templates have been converted to System Data Sources to be used globally within elluminate. Any study / global data store data sources that were derived from templates will become study / global data store data sources that inherit information from the system data source. Changes made to data sources at the system level will update all instances of the data source at study / global data store or import level.

System Data Sources

Users with the System Configure privilege can create, edit, and delete system data sources. When creating a new data source, users can choose from data sources already configured at the system level and can edit all fields.

Columns within the list of system data sources are Name, Description, Type, Last Modified, Last Modified By, and Usage Count. The Details view for a data source displays at the right.

Create a New System Data Source

From the Platform Menu select System Data Sources under Platform Administration.
Click the New button in the Master Header. A New Connection window opens.
Name: Enter the name of the new data source (name must be unique). You may use any combination of letters, numbers, characters, and spaces.
Description: Enter a description of the data source.
Use System Data Source: Optionally, click the drop-down to select an existing data source. All details are automatically added from the selected data source except for the Name and Description.
Data Source Type: Click the drop-down to select the data source type. This option is greyed out if an existing data source is selected in the above drop-down. For details on each data source type see below.
Click Save.

Edit a System Data Source

Changes made to a system data source will automatically update all study data sources derived from that system data source.

From the Platform Menu select System Data Sources under Platform Administration.
Click in the row of the Data Source you wish to edit.
Click the Edit button. The Edit Connection window opens.
Make the changes.
Click Save.

Delete a System Data Source

From the Platform Menu select System Data Sources under Platform Administration.
Click in the row of the Data Source you wish to delete.
Click the Delete button. A confirmation message displays to confirm you want to delete the connection.

Note: A message may display indicating it cannot be deleted because other connections depend on it.
Click OK to delete, or Cancel to cancel your action.

Study / Global Data Store Data Sources

Users with the Study Configure privilege, can create, edit, and delete study / global data store level data sources. These users can choose from data sources configured at the study / global data store or system level and can edit all fields at the study / global data store level. Edits made at the study / global data store level will only apply to data source usage within the study / global data store.

Create a New Study Data Source

From the Platform Menu, select Data Sources under Study / Global Data Stores Management.
Select a study / global data store from the right side of the Platform Menu.
OR
Access a study from the Studies Home Page / global data store from the Global Data Stores Home Page.
Select Data Sources from the Module drop-down. The list of existing data sources displays.
Click the New button in the Master Header. A New Connection window opens.
Name: Enter the name of the new data source (name must be unique). You may use any combination of letters, numbers, characters, and spaces.
Description: Enter a description of the data source.
Use System Data Source: Optionally, click the drop-down to select an existing system data source. All details are automatically added from the selected data source except for the Name and Description.
Data Source Type: Click the drop-down to select the data source type. This option is greyed out if an existing data source is selected in the above drop-down. For details on each data source type see below.
Click Save.

Edit a Study Data Source

From the Data Sources page for a study or global data store, click in the row of the Data Source you wish to edit.
Click the Edit button. The Edit Connection window opens.
Make the changes.
Click Save.

Delete a Study Data Source

From the Data Sources page for a study or global data store, click in the row of the Data Source you wish to delete.
Click the Delete button. A confirmation message displays to confirm you want to delete the connection.
Click OK to delete, or Cancel to cancel your action.

Promote a Study Data Source to a System Data Source

Users with the System Configure privilege can promote a study data source to a system data source.

From the Data Sources page for a study or global data store, click in the row of the Data Source you wish to promote.
Click the Promote button. The Promote Connection window opens with all fields populated from the selected data source except for the Name and Description.
Name: Enter the name of the new data source (name must be unique).
Description: Enter a description of the data source.
Click Promote. The promoted data source is added to the System Data Sources.

Note: When creating a Data Source for a Global Data Store, only the following data sources are available: Amazon S3, Amazon S3 Outbound, Box, Box Outbound, FTP, FTP Outbound, and Nurocor MDR.

Important: All Rave data sources require a Rave user account created specifically for this purpose. Please complete the steps detailed in the Set up Rave Web Service User Account section prior to creating the Rave data source.

Data Source Types

Click a Data Source from the list below for specific instructions relevant to that data source type:

Amazon S3
For use with Amazon S3 storage bucket.

Name and Description: Confirm they have been entered appropriately.
Bucket Name: The name of the S3 bucket that contains the data.
Access Key: The Access key for the Amazon account that can read from the S3 bucket.
Secret Key: The Secret key associated with the source system account.
Amazon S3 Region: The Amazon Region that your S3 bucket with the data resides in.
Remote Files: Enter the data files you want to import from the source system folder. Use the * as the wildcard. For example, *.xlsx will import all xlsx files from the selected folder.
Remote Folder: Enter the folder for the source system folder.
Role: Roles can be specified in the S3 bucket.
Box
The Box for Enterprise (Box) data storage software is a data source for imports to elluminate. Used as an alternative to Amazon S3 and SFTP.

Name and Description: Confirm they have been entered appropriately.
Box Application Configuration: Cut and paste the contents of the Box Application Configuration JSON file.
Remote Files: Enter the data files you want to import from the source system folder. Use the * as the wildcard. For example, *.xlsx will import all xlsx files from the selected folder.
Remote Folder: Enter the folder for the source system folder.
Formedix MDR
The Formedix repository can be used to import and upload custom standards into the elluminate Standards module. Only available for system data sources.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
API Key: Web Service key provided by source system to define the study and authenticate access.
Secret Key: The Secret key associated with the source system account.
FTP (including SFTP and FTPS, and used for Covance)
File Transfer Protocol: a standard network protocol used to transfer files from one host to another host over the Internet.
elluminate supports both SFTP and FTPS.
Covance data can be imported into elluminate via FTP and used in configuring and mapping data in the Operational Data Repository (ODR).

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system.
Password: Enter the password that will be used to access the remote system.
Remote Files: Enter the data files you want to import from the source system folder. Use the * as the wildcard. For example, *.xlsx will import all xlsx files from the selected folder.
Remote Folder: Enter the folder for the source system folder.
Medrio
Web service connection to Medrio's EDC platform.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
API Key: Web Service key provided by source system to define the study and authenticate access.
Merge (Zelta)
Web service connection to Merge’s (Zelta's) EDC platform.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system.
Password: Enter the password that will be used to access the remote system.
Environment: UAT or PROD, for example. If an environment is not specified, PROD will be assumed.
Remote Study ID: Enter the name of the study ID to access the source system.
Nurocor MDR
The Nurocor repository can be used to import and upload custom standards into the elluminate Standards module. Only available for system data sources.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Library: Select from the version of Nurocor to be used.
APIKey: Web Service key provided by source system to define the study and authenticate access.
ODBC
This data source provides configuration options to establish connections to external Open Database Connectivity (ODBC) compliant SQL or Snowflake databases to import datasets for use within elluminate.
Configure this data source using the target server with the appropriate ODBC driver installed, relevant credentials, target database, and other options. Once configured, users can test the connection and configure import definitions to ingest data from the external SQL or Snowflake database.
The same data source can be used to export data to the configured database, similar to the existing functionality where users can push files to an external file storage system like an sFTP server or Box directory. Datasets can be pushed through the configured ODBC data source to the target SQL or Snowflake database.

Name and Description: Confirm they have been entered appropriately.
Driver: Select from the drop-down: SQL Server or Snowflake.
Server: Enter the server URL.
UId: Enter the user ID that will be used to access the remote system.
Pwd: Enter the password that will be used to access the remote system.
Database: Enter the name of the database.
Additional Options: Enter additional options details.
Test Connection: Click to test the connection.
Oracle Health Sciences InForm Discrepancy
InForm Queries can be imported into elluminate and supports 2-way query integration.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system.
Password: Enter the password that will be used to access the remote system.
Tenant Prefix: Enter the name of the tenant prefix.
Remote Study: Enter the name of the study to access the source system.
PPD - Deprecated
PPD data can be imported into elluminate and used in configuring and mapping data in the Operational Data Repository (ODR) module.

Name: Enter the name for this import. You may use any combination of letters, numbers, characters, and spaces.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system.
Password: Enter the password that will be used to access the remote system.
Description: Enter a description of the data being imported.
Rave
Accesses Rave’s Clinical, Operational and audit data to import into elluminate

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system. The user must have both Read Only and Architect access.
Password: Enter the password that will be used to access the remote system.
Environment: UAT or PROD, for example. If an environment is not specified, PROD will be assumed.
Remote Study: Enter the name of the study to access the source system.
Trial Master
Data from OmniComm Trial Master EDC can be imported into elluminate and used in configuring and mapping data to be displayed and reviewed in Data Central and in the CDA Analytics application.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
User: Enter user (user@trialgroup)
Password: Enter the password that will be used to access the remote system.
Remote Study: Enter the name of the study to access the source system.
Veeva
eTMF and operational data from Veeva can be imported into elluminate and used in configuring and mapping data in the Operational Data Repository (ODR).

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system.
Password: Enter the password that will be used to access the remote system.
Veeva CDMS
Provides configuration options to establish connections to Veeva's Clinical Data Management System for importing operational data, enabling users to engage in 2-way querying with Veeva CDMS and access other beneficial tables like subject data, site data, forms, events, and more. This data source is used to create a corresponding import definition to import operational data for mapping, viewing in Data Central, and exporting from elluminate.

Name and Description: Confirm they have been entered appropriately.
Address/URL: Enter the entire URL from which the data will be imported.
Username: Enter the username that will be used to access the remote system.
Password: Enter the password that will be used to access the remote system.
Environment: Enter environment name.
Remote Study: Enter the name of the study to access the source system.

Note: After a Data Source has been defined, it can then be used in the Importer or Exporter modules.

Rave Integration Overview

As a clinical data repository, the more data you get into elluminate, the more value you get out of it. With the elluminate importer, there are three options for importing data: manual file import, FTP server, or web service integration. While your method of import may vary from one vendor/source to the next, it is most common - and strongly recommended - to utilize the web service integration for high volume and high frequency sources such as EDC systems. This is especially true with Medidata Rave, as eClinical Solutions offers an out-of-the-box web service that pulls data from Rave and enables near-time reporting and analysis within elluminate. This Rave web service integration also opens the door to advanced elluminate modules such as Clinical Trials Operational Analytics reporting and the Data Central.

There are three sequential steps in establishing a web service integration between elluminate and Medidata Rave. Each step is explained in detail at the linked page.

Set Up Rave Web Service User Account

Perform the following steps in Medidata Rave to setup a Rave user account to be used for the web service connection.

The user completing the following task must have access to the User Administration module within Rave and have experience in setting up and activating Rave user accounts.

Login to Rave, access User Administration, and initiate the creation of a new user.
Complete the fields indicated below (in red) to create a generic user that is specific to the elluminate integration (such as "elluminate_integration") and not linked to an individual person. We recommend selecting a PIN that does not have personal connection, as it will be necessary to share this password while establishing and testing the web service integration.
Once complete, click the Update button to create the user and generate an Activation Code.
Copy the Activation Code.
Go the Rave URL in a separate Web Browser and activate the account
Click the Activate New Account link.
Click the Activate New Account link; copy the Activation Code and enter the PIN entered in Step 2 above.
Enter a password which is easily remembered. Once done, click the Save Password and Continue button.
The screen below will appear if the password is accepted. Click the Logout button in the upper-right corner.
Login to Rave as an Administrator. Access User Administration and change the "Password Expires" year to 9999 and click the Update button
Go back to the account in Rave User Administration and update the following. Assign the Study/Environment accordingly. The role should have access to all fields with the study; typically, Power User.
Click the Update button after the Training section is done.