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

To configure data blinding, users need both the Blinded Data Configure and Study Configure privileges. The Blinded Data Configure privilege enables users to create, edit, import, export, and delete blinding configurations, but does not grant access to view unblinded data.

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 + Add Study in the master header. The Add Study window opens.
   
2. To add a study from a template, click the Templates icon and select Add From Template.

   1. In the Select Template window, choose the desired template and click Select.

      Note: For details on creating and managing study templates, see the Create and Manage Study Templates article.

      

3. In the Add Study window, complete all five tabs that define the study characteristics: Configuration, Standards, Dictionaries, Settings, and ETL. See the sections below for details on completing each tab.
4. Click Save. The Add Study window closes.

Tip: Click Save only after completing all five tabs. Saving closes the Add Study window. If the study was saved before completing all tabs, go back into the study and edit it.

Complete the Configuration Tab

Use the Configuration tab to configure key study details.

Note: Drop-down menus provide study attribute selections configured for the URL.

Note: Only Study Name and Compound are required on this tab. However, selecting a Compound, Therapeutic Area, and Program is recommended to ensure proper grouping in the CDA and CTOA Analytics apps.

1. Study Name: Enter the required name (2-24 characters, must begin with a letter or number; underscores, hyphens, and spaces are allowed after the first character; special characters are not allowed). Invalid entries highlight the field in red and disable saving.
2. Compound: Select from the drop-down menu (required).
3. Description: Enter a description of the study.
4. Phase: Select from the drop-down menu.
5. Indication: Enter the indication.
6. Therapeutic Area: Select from the drop-down menu.
7. Program: Select from the drop-down menu.
8. Program Type: Select the applicable checkbox(es) to indicate whether the study includes randomized and/or stratified subjects.
9. Blinding: Select from the drop-down menu. For blinded studies, select an option that indicates the study is blinded.
10. Control: Select from the drop-down menu.
11. Study Type: Select from the drop-down menu.
12. Primary Endpoint: Select from the drop-down menu.
13. Healthy Subjects: Select Yes or No.
14. Select the Standards tab.

Complete the Standards Tab

On the Standards tab, select the applicable CDISC standards for the Data Quality module and the study. Use the drop-down menus to choose from the available versions in Pinnacle 21.

• 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.

Select the Dictionaries tab.

Complete the Dictionaries Tab

Use the Dictionaries tab to select the MedDRA version, UNII Date, and NDF-RT Date for the study. Use the drop-down menus for each selection.

Select the Settings tab.

Complete the Settings Tab

Use the Settings tab to enable study status, licensed products, analytics applications, and study-level feature settings.

Note: The Add / Edit Study window displays only the products and features available for the URL and licensed by the client.

• Active (enabled by default): Toggle on to make the study visible to authorized users (without Administration or Study Configure privileges) on the Home Page.
• Ongoing (enabled by default): Toggle on to identify the study as active. Toggle off to designate the study as legacy. Scheduled imports stop 30 days after the 'Ongoing / Legacy As Of' date. Only eClinical Administrators can update this setting.
  • Ongoing As Of: Defaults to the study creation date. Update the date using the calendar picker or by typing a date.
• Blinded Data: Toggle on when the study includes blinded data. Configure blinding rules on the Data Blinding tab after saving the study.
• Data Central: Toggle on to enable Data Central for the study. When enabled, the system identifies new and updated records since the last import.
  • eIQ Review: Available when Data Central is enabled. Toggle on to enable eIQ Review for the study. When enabled, eIQ Review models can be configured.
  • elluminate Assist: Available when Data Central is enabled. Toggle on to enable elluminate Assist for the study, then select the SDTM Data Store from the drop-down menu. If no data store is selected, the system defaults to the Reporting data store.
  • Data Advisor: Available when Data Central is enabled. Toggle on to enable Data Advisor for the study.
  • Protocol Deviations: Available when Data Central is enabled. Toggle on to enable Protocol Deviations for the study.
  • RBQM & RACT: Available when Data Central is enabled. Toggle on to enable RBQM & RACT features for the study.
• Data Quality: Toggle on to enable Data Quality for the study. When enabled, study data structures can be validated against CDISC standards using the standard selected on the Standards tab.
• Pinnacle 21 Enterprise Validation: Toggle on if Pinnacle 21 Enterprise is used to validate the study data structure. The client-provided API Key and Web Host must be configured at the URL level.
  1. Click the Configure icon on the right. The Pinnacle Enterprise Validation Study Configuration window opens.
  2. Enter the client-provided Pinnacle 21 Enterprise details: Project, Study, and Data Package.
  3. Click Save.
     
     

• Clinical Data Analytics: Toggle on to enable Clinical Data Analytics for the study. When enabled, standard study visualizations are available in the Clinical Data Analytics application.
• Clinical Trial Operational Analytics: Toggle on to enable Clinical Trial Operational Analytics for the study. When enabled, operational visualizations are available after an ODM import.
  • Data Store for Queries: Defaults to ODM_Mapped. If the study does not use Rave, select the data store used for queries. If Data Central and queries are enabled, this value must match the Data Store Queries Table configured in the study Data Central Configuration.
• Sample Management Analytics: Toggle on to enable Sample Management Analytics for the study.
• Source Data Analytics: Toggle on to enable Source Data Analytics for the study.
• Statistical Computing Environment (SCE): Toggle on to enable SCE for the study when licensed by the organization.
• Data Classification: Toggle on to enable Data Classification for the study when licensed by the organization.
• Mapping Automation: Toggle on to enable Mapping Automation for the study when licensed and SCE is enabled.
  • Select Source Data Store(s): Select one or more source data stores from the list.

Select the ETL tab.

Complete the ETL Tab

ETL (Extract, Transform, and Load) is used for mapping key study variables and overrides for each data store, and for activating the Data Variance and Reporting Database for each data store. The validate icon verifies entries in the Domain Specific Keys table for validity and uniqueness. It displays a warning if a configured field does not exist in some domains or if a key is not unique across domains. Users can also set a 0-100% threshold to limit the number of records with changes in an imported dataset for a successful import.

• Schema Prefix: This is automatically populated after study creation.
• Study Import Control
  • Enable Changed Data Records Threshold: Select to enable study import control.
  • Threshold (%): Enter a threshold between 0 and 100% to limit the amount of records with changes in an imported dataset for successful import.
    • When importing into a study with a configured change percentage, files with enabled Data Change Tracking and properly configured keys are compared against the previous import of the same file. This determines if the change between the current and previous imports exceeds the configured threshold.
    • If the threshold is exceeded, the import completes with a warning that the change exceeds the allowed limit and the file was not imported.
    • Files with a percentage change below the threshold are imported without warning.
• Reporting Database
  • See the Configure and Manage the Reporting Database article for details on configuring the Reporting Database.
• Show all data stores: Select to list all data stores in the Key Study Variables table.

• Key Study Variables: Keys define a minimal set of fields for each domain or data store, uniquely identifying each record across all domains within that data store. Defined keys are required to enable change tracking within Data Central during data import. Change tracking (issue creation, comments, annotations, and review marking) is disabled for duplicate keys. Domain data in Data Central becomes read-only if keys are duplicated or undefined at import. Keys can be validated in both study and Data Central configurations; key overrides can be configured in 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.

  • Keys must be configured for each data store in a study, but only after data import. Key definition is only required for studies not using Rave, TrialMaster, InForm, Veeva, InForm Repeating, Veeva Lab, Rave Lab, Preclarus Lab Samples, or Preclarus Lab Results; these systems automatically define keys.
  • Data Variance can be enabled when creating a study. Enabling it for a data store adds a Data Variance icon to its domain listings in Data Central. This allows users to specify a date range and identify new, updated, or deleted records in those domains.
  • Overrides: Before adding overrides, ensure automatic key definition is working correctly. Enter a comma-separated list of non-changing, non-nullable fields present in the domain and applicable across all domains in that data store. Ideally, these fields can be combined to uniquely identify records (e.g., Site and Subject ID).
  • Validate: Click to verify the entries in the Key Study Variables table for validity and uniqueness. A detailed warning displays if a field does not exist in a domain or if the key is not unique across domains.

After configuring the five tabs, click Save.

Complete the Data Blinding Tab

Data Blinding controls the visibility of sensitive study data through configured rules and user privileges. Authorized users can access data while restricted users see masked values or hidden records. Blinding can be applied at the field level or row level and applies to both source and derived data. Source domains use configured blinding rules to protect imported data. Derived domains created through transformations, such as Mapper transformations, require separate blinding rules. Blinding configured on source domains does not automatically propagate to mapped or derived outputs. Review mapped and derived domains to ensure sensitive values remain blinded in downstream outputs.

Note: Blinding does not modify the underlying source data. The platform dynamically controls how data is displayed based on user privileges and configured blinding rules.

Configure Data Blinding only after saving a study; this tab is unavailable when adding a new study. It is best to configure blinding before importing data.

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

Configure data blinding at the field and row levels.

On the Configuration tab, ensure a blinding option is selected (e.g., Single Blind, Double Blind).

On the Settings tab, ensure Blinded Data is enabled.

Note: A Rave account must be blinded to ensure ODM_Mapped data is blinded.

Add Blinded Fields Individually

1. From the Data Blinding tab, click the Add icon.
   
2. Data Store: ‘All Data Stores’ is selected by default. Use the drop-down menu to select an individual data store listed under ‘Data Mart’ or ‘Staging Area’ where the field to be blinded resides.
3. Domain: Type the domain name, select it from the drop-down menu, or use wildcard options.
4. Field: Type the field name, or select it from the drop-down menu, use a comma-separated list, or use wildcard options.

5. Mask: Optionally, enter a mask value.

   Tip: This field can be left blank or a value can be entered. If left blank, the column for the blinded field displays as null (blank). If a value is entered in the Mask field, all blinded data that are null continue to display as null (blank), and all other values 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 system masks values as '1/1/0001' for date and datetime and '-1' for all numeric types. Mask values applied to string or character fields that exceed the original field length are truncated.

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

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

Configure Row-Level Blinding

Row-Level Blinding uses a SQL-based approach that requires only conditional statements to select the data records to blind. The simplified condition structure supports users without SQL experience.

Note: For SQL-experienced users, the Row Condition statement should contain the filter conditions following the ‘WHERE’ clause in the query. For example, ‘SELECT * FROM table WHERE [row conditions]’.

‘AND’ and ‘OR’ statements are supported. Use parentheses ‘( )’ to group conditions and control evaluation order, similar to mathematical order of operations.

Examples:

Export and Import Study Blinding Configurations

Users can export study blinding configurations to an Excel file and import that file into another study or into the same study on a different elluminate URL. This supports reuse of existing blinding configurations across studies and environments. During import, the system validates the file, identifies structural or content changes, and displays counts of added, deleted, and modified blinding records before updates are applied.

1. In the source study, click the Export Blinding icon. The Excel file downloads.

2. Save the exported file locally.

3. Open the target study where the configuration will be applied.

4. Click the Import Blinding icon. The Import Blinding Configuration window opens.

5. Drop the file or click to browse and select the exported Excel file. The system validates the imported file and checks for differences from the existing blinding configuration before changes are applied.

6. Review the validation results and confirm that the file structure and contents are correct.

7. Review the counts of added, deleted, and modified blinding records identified during staging.

8. Review the staged changes, then confirm the update to apply the imported blinding configuration.
   

9. Click Import.

Best Practices When Configuring a Study

• Configure Study Attributes. Before adding a study in elluminate, go to Platform Administration → Configuration to set up Study Attributes. Configured attributes populate the drop-down menus used when adding a study and enable proper grouping in the CDA and CTOA Analytics applications.
• Use 'Add From Template' whenever possible. Study templates provide reusable blueprints for new studies and prepopulate common choices across the five tabs. Templates enable straightforward setup, consistent standards and dictionaries across trials, and reduced configuration drift. Maintain a small, curated library of study templates and version the library as organizational needs evolve.
• Enforce a concise, searchable naming convention. Follow elluminate rules for Study Name: 2 to 24 characters, must start with a letter or number, and only underscores, hyphens, or spaces are allowed after the first character. The study name becomes the schema prefix in the elluminate database; keep the name short, simple, and effective.
• Complete all five tabs before saving. elluminate recommends filling out the tabs (Configuration, Standards, Dictionaries, Settings, and ETL) and saving only after all tabs are complete to avoid closing the Add Study window in the middle of setup. Many settings depend on each other; for example, enabling Clinical Data Analytics on the Settings tab requires selecting an SDTM standard on the Standards tab.
• Select standards & dictionaries deliberately and document them. Choose SDTM and ADaM standards with corresponding Controlled Terminology (CT) dates and dictionary versions. Record the selections and avoid changes during the study unless governed by change control. Maintaining consistent standards, controlled terminology, and dictionaries ensures data quality, analytics, and external validation (e.g., Pinnacle 21 Enterprise) results.
• Configure blinding before the initial data import. Save the study to enable the Data Blinding tab. Select a blinding option on the Configuration tab, enable Blinded Data on the Settings tab, and configure blinding rules before importing data. This helps ensure sensitive source data are blinded from the start and reduces the risk of exposing unblinded values in downstream features and outputs.
• Blind all instances of sensitive variables. Apply blinding anywhere a sensitive field appears or is derived, including copies, recodes, flags, joins, and aggregates. This helps maintain consistent masking across source and derived data. For example, if ARM is blinded in staging, also blind ARMCD and related treatment labels in SDTM and Reporting.
• Export and import blinding configurations to maintain consistency. Use the Export Blinding icon to download the study’s blinding configuration and apply it to another study or environment using the Import Blinding icon. This supports consistent blinding rules across studies and reduces setup effort when replicating an existing configuration.