Permissions: Administrators with the View and Study Configure privileges can add new studies to elluminate.

Important: Study Attributes should be configured prior to adding a new study. For more details see the 'Configure Study Attributes' article in the Administration section.

Studies are created within elluminate as a centralized environment to collect, organize, manage, and access all relevant data. New studies can be created manually or from an existing template.

Add a New Study

1. From the Studies page, click the plus sign in the Master Header. 
   You can also click the drop-down arrow to add a new study based on a template. To see the available templates, click the drop-down arrow and select Templates from the list.

   

2. If you selected New from Template, the Select Template window appears.
3. Select the Template you wish to use and click Select.
   

The Add New Study window displays. There are five tabs used to define the characteristics of the study:

• Configuration
• Standards
• Dictionaries
• Settings
• ETL

Tip: It is best practice to identify the Compound, Therapeutic Area, and Program when configuring a study. This is important if the CDA and CTOA apps in Analytics will be configured to be grouped by Compound, Therapeutic Area, or Program.

Configure Configuration Items

Use the Configuration tab to enter key study details and select from configuration items.

1. Study Id: Enter the name of the study; this is a required field.

   • A Study Id must begin with either a letter or a number.
   • A Study Id can be between 2 and 25 characters in length.
   • An underscore, hyphen, or space may be used as part of the Study Id, but not as the first character. Other special characters are not accepted.
   • A Study Id that is not acceptable will result in the field turning red; you will not be able to save the record until the error is corrected.

   
    

2. Description: Enter further information to describe the Study; this is an optional field.
    

3. Drop-down selections: Choose the appropriate option from each drop-down. 

   Note: It is recommended that a Compound, Therapeutic Area, and Program are selected, as selection here affect groups within the CDA and CTOA Analytics apps.

4. Randomized & Stratified: Select the checkbox(es) to indicate whether the study model includes randomized and/or stratified subjects.
    
5. Blinding: Select from the drop-down: Double Blind, Open Label, or Single Blind.
6. Control: Select from the drop-down: Active, Placebo, or None.
7. Primary Endpoint: Select from the drop-down. The drop-down will contain Endpoints configured for the URL.

8. Healthy Subjects: Select Yes or No, as applicable.

   Note: Study Id and Compound are the only two required fields on this tab.

9. If you want to enter additional information about your study, enter data on all the appropriate tabs, and then click Save.
   To create a Template based on these study selections, click Save as Template. This will allow you to use the settings you configure as a template for future studies.

Configure Standards Used

Use Standards to identify the Standards used in the Data Quality module for the study. Click on the drop-down arrows to see the versions available and make your selections. The lists are defined by the available versions of CDISC standards available in Pinnacle21. Options include:

• SDTM Standard (CDISC Study Data Tabulation Model)
• SDTM CT Date (SDTM Controlled Terminology)
• ADaM Standard (CDISC Analysis Data Model)
• ADaM CT Date (ADaM Controlled Terminology)
• Define-XML Standard 

Note: The selected standard versions are used for Data Quality only. Custom standards, non-CDISC standards, or versions not listed on this screen can be applied separately in Mapper or Validator.

Important: The SDTM Standard must be selected if using the Standard Analytics (Clinical Data Analytics or Clinical Data Analytics-- Oncology).

Configure Dictionaries

Use Dictionaries to select the MedDRA version, UNII Date, and NDF-RT Date to be used in the study. Click the drop-down for each field and make your selections.

Configure Operational Settings

Use Settings to define the operational settings for your study. 

Note: When creating a new study, only modules or products for which the client holds an active license will be available to enable and will appear in the Add / Edit Study window under the Settings tab. 

• Active: Check if you want other authorized users, with non-Administration or Study Configure privileges, to be able to see this study on their Home Page. 
• Ongoing: This is checked by default and indicates the study is in use. When unchecked, it indicates the study is considered a legacy study and scheduled imports will stop 30 days after the date listed in the 'Ongoing / Legacy as of' date field. This checkbox can only be altered by an eClinical Administrator. 
• Ongoing As of: Enter the Ongoing As Of date by typing in the date or using the calendar. The date defaults to the date you created the study.
• Has Blinded Data: Check if the study contains blinded data. Use the Data Blinding tab to configure blinding.
• Allow Data Review: Check to enable the Data Central module within elluminate. This allows the system to identify and include the records that are new or updated since the last import. 
• Enable elluminate modules. Only licensed modules will be listed.
  • Enable eIQ Review: Check to enable eIQ Review for the study. The URL must also have this feature enabled.
  • Enable Protocol Deviations: Check to enable Protocol Deviations for the study. The URL must also have this feature enabled.

  • Enable Data Quality: Check to enable the Data Quality module, allowing for validation of the study data structure against CDISC Standards.

    Note: The Data Quality module will use the standard selected on the Standards tab. [See above]

  • Enable Pinnacle 21 Enterprise Validation: Check to enable if Pinnacle 21 Enterprise will be used to validate study data structure. (At the URL level configuration, the client provided Api Key and Web Host were added.)
    • Click the Configure icon at the right. The Pinnacle Enterprise Validation Study Configuration window opens. Enter the client provided Pinnacle 21 Enterprise details: Project, Study, and Data Package, then click Save. 
      
  • Enable Clinical Analytics: Check if you want to be able to view the standard data visualizations for this study in the Clinical Data Analytics (CDA) applications. These visualizations are available from the Analytics module.
  • Enable Operational Analytics: Check if you want to be able to view the operational data visualizations in the Clinical Trial Operations (CTOA) or CTOA-Advanced after an ODM import. These visualizations are available from the Analytics module.
    • When this option is selected, the drop-down defaults to ODM_Mapped. If your study does not use Rave, you must select the Data Store that will be used for Queries. If you have the Data Central module enabled, and are enabling queries, this must match the Data Store Queries Table. See the Data Central section for more details on Data Central configuration.
  • Enable Custom Analytics if you want to be able to access Source Data Analytics. These visualizations are available from the Analytics module.
  • Enable RBQM & RACT: Check if your organization has contracted for use of elluminate's RBQM (within Data Central) and RACT modules.
  • Enable SCE: Check if your organization has contracted for the use of elluminate's SCE product.
  • Enable Data Classification: Check if your organization has contracted for an eIQ license.

Configure ETL Mapping

ETL (Extract, Transform, and Load) is utilized for mapping purposes, enabling the identification of key study variables and overrides for each Data Store, along with the activation of Data Variance and Reporting Database for each Data Store. The validate icon verifies the entries in the Domain Specific Keys table for validity and uniqueness. It displays a warning if a user configures a field that does not exist in some domains or if the key itself is not unique across the domains. Additionally, users have the option to set a percentage threshold between 0-100% to limit the number of records with changes within an imported dataset for a successful import.

Important: It is recommended that you do not use the advanced settings unless instructed by eClinical Solutions. Leaving these options unchecked/unchanged ensures that the data in elluminate is consistent with the source data.

• Schema Prefix:
  • Automatic Date Conversion: This is a deprecated setting to support studies in older versions of elluminate. Control is disabled and cannot be checked or unchecked. Formerly caused variables with certain naming conventions to be converted during the import process.
  • Add Date Part Components: This is a deprecated setting to support studies in older versions of elluminate. Control is disabled and cannot be checked or unchecked. Formerly caused dates to be broken down into day, month, and year components automatically during the import of your source data, changing how it is displayed in the Staging Area from the actual source.
  • Generate Default Mapping: This is a deprecated setting to support studies in older versions of elluminate. Control is disabled and cannot be checked or unchecked.
• Study Import Control
  • Enable Missing Data Records Threshold: Check this to enable study import control.
  • Threshold (%): Enter a threshold between 0-100% to limit the amount of records that have changes within an imported dataset for the file to import successfully. 
    • When running an import on a study with the percent of changed data configured, any files being imported that have Data Change Tracking enabled and proper keys configured will be compared against the previous import of the same file. This determines if the amount of change is between the current and previously imported file exceeds the configured threshold.
    • When the threshold is exceeded, the import will complete with a warning that notifies the users that the change in the imported file is greater than what is allowed and has not been imported.
    • Any files imported with a percent change below the threshold will be imported without warning.
• Reporting Database
  • Please refer to the Configure and Manage the Reporting Database article for details on how to configure the Reporting Database.
• Show all data stores: Checked by default to list all Data Stores in the Key Study Variables table.

• Key Study Variables: Defined keys are required to enable change tracking within Data Central when data is imported into a domain. Change tracking (issue creation, comments, annotations, and marking data as reviewed) will also be disabled for duplicate keys. Domain data in Data Central becomes read-only when keys are duplicates or not defined at import. Keys can be validated in both the study configuration and Data Central configuration. Key overrides can be configured within the study configuration.

  Important: It is important to configure key variables for the data stores before the first import to support features such as Data Variance.

  • Domain Specific Keys for each data store in each study need to be configured, but is not available until data have been imported into the data store. Keys must be defined for non-Rave studies (keys are automatically defined for Rave studies).  
  • Data Variance can also be enabled when creating a study. Enabling Data Variance for a data store adds a Data Variance icon to domain listings in that data store. Using Data Variance, users can input a date range to identify new, updated, or deleted records. 

Configure Data Blinding

Data Blinding can be configured after a study has initially been created, but not when you are adding a study for the first time. The Data Blinding tab becomes available once a study is saved. It is best to configure blinding prior to importing data.

Only users with the Blinded Data Configure privilege have access to the Data Blinding tab.

Data blinding can be configured at the field and row levels.

In the Configuration tab confirm that a blinding option is selected (e.g., Single Blind, Double Blind). 

In the Settings tab confirm Has Blinded Data is checked.

Note: It is important that a Rave account be blinded in order to blind ODM_Mapped data.

Add each field individually to be blinded:

1. From the Data Blinding tab, click the '+' sign.  
   
2. Click the Data Store drop-down and select the Staging Area or Data Mart from where the field to be blinded resides.
3. Enter the Domain name, or use wildcard options.
4. Enter the Field name, a comma-separated list, or use wildcard options.

5. Optionally, enter the specified Mask. 

   Tip: This textbox field can be left blank, or a value entered. If left blank, the column for the blinded field will be Null (blank). If a value is entered in the Mask field, all blinded data that are NULL will continue to display as Null (blank), all other values will display as the specified mask. If the specified mask cannot be converted to the field data type (e.g., 'xx' for date, datetime, int, or decimal), the values will be masked as '1/1/0001' for date and datetime, and '-1' for all numeric types.

6. Click the Row Level Condition icon in the Row column to add row-level blinding. For more details see the Row-Level Blinding section below.
   
7. Enter the SQL condition. (See examples below.)
8. Click OK.
9. Repeat the steps to add more fields.
10. Click Save.

To remove a row, click the Delete Blinded Field icon at the right of the field.

Row-Level Blinding

Row-Level Blinding uses a SQL-based approach that only requires conditional statements by the user to select which data records are applicable for blinding. While the approach is based on SQL, isolating these conditions makes it simple for a user with no SQL experience to define conditions of blinding.

(For curious SQL-experienced users, the Row Condition statement should be the filter conditions that would follow the ‘WHERE’ statement in your query – i.e. ‘select * from table where [row conditions]’)

‘AND’ and ‘OR’ statements are supported, and the best way to define these statements is through grouping conditions as needed using parentheses (, ). Those conditions nested within parentheses are evaluated as a group, much like the order of operations in mathematics.

Examples: