Use this glossary to help understand the terminology as it applies to elluminate.
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| ADaM (Analysis Data Model) | ADaM is a CDISC standard that outlines the structure of datasets used for statistical analysis and regulatory submissions. ADaM datasets are derived from SDTM data and are prepared to support clinical trial analysis. |
| Advanced Filter | A reusable filter in Data Central that allows users to create complex filtering logic across multiple domains. Advanced Filters can be saved and used across various workspaces and studies for data review. |
| Adverse Event (AE) | An adverse event (AE) is any unfavorable medical occurrence in a subject, regardless of whether it is related to the investigational product. In elluminate, AE data is reviewed in Data Central listings and analyzed in Analytics sheets. |
| Adverse Event of Special Interest (AESI) | This adverse event is flagged for additional monitoring due to its clinical importance or potential safety concerns. AESIs are identified within the standard AE domain based on predefined study-level or subject-level criteria. AESIs can be reviewed and analyzed through Data Central listings, Data Central Visualizations, and the Clinical Data Analytics (CDA) app. |
| Aggregate | Aggregate refers to the calculation or display of summarized data values, such as counts, totals, averages, or percentages, derived from multiple records within a dataset in elluminate. |
| Analytics | An elluminate product that provides comprehensive data visualization for optimized data review and operational insight. |
| Annotation | A user-defined column which can be added to subjects, queries, issues, or data domains and listings for the purpose of recording observations within Data Central. |
| Anomalous Record | A record identified by an eIQ Review model as potentially inconsistent, incorrect, or outlying based on machine learning analysis. |
| API Credentials | API Credentials consist of the API Key and API Secret generated within a user profile in elluminate. They are used to authenticate secure outbound or integration connections between elluminate and external systems. |
| App | An application within Analytics that provides specific types of data visualization. |
| Assessment (RACT Assessment) | A structured risk evaluation conducted within RACT to identify, assess, document, and manage study-level risks. An assessment captures risk statements, scoring, mitigation strategies, and monitoring plans to support risk oversight throughout the study lifecycle. |
| Audit Logs | A module within elluminate that tracks actions performed by elluminate users. It is fully compliant with 21 CFR Part 11 audit trail requirements. |
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| Badge (Filter / Review Indicator) | A badge is a visual indicator used throughout elluminate to show counts and status at a glance. Blue badges show the number of records currently displayed or filtered; red badges highlight items needing attention, such as open Issues, Queries, or records to review; green badges signify completion or no outstanding items; and gray badges indicate no pending activity. |
| Baseline | In elluminate, baseline usually refers to the first recorded value for a subject, used as the reference point for comparison in analysis. |
| Blinding (Blinded Data View) | Blinding involves hiding specific data from certain users to protect the study's integrity. In elluminate, the Blinded Data View privilege determines which users can see particular fields or records during data review or analysis. |
| Bookmark (Analytics) | A Bookmark is a saved view that captures the current filter selections within an Analytics app. Bookmarks can be applied across sheets within the same app, allowing users to quickly return to or reuse a predefined filtered state without manually reapplying the selections. |
| Box and Whisker Chart | A Box and Whisker Chart visualizes the distribution of numeric data by showing the median, quartiles, and range. It helps identify variability, spread, and potential outliers within a dataset and can be created in Data Central Visualizations. |
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| Card View | Card View is a display format in elluminate that shows records or objects as individual cards rather than in rows in a grid. It lets users review key attributes, status indicators, and related metrics in a summarized, visual layout. |
| Cascade Changes | Cascade Changes is a Mapper configuration option that enables updates or transformations in a parent mapping layer to automatically propagate to dependent child layers when variables or domains are changed. |
| CDA app (Clinical Data Analytics app) | An app within Analytics which facilitates data exploration across domains, studies, and compounds to identify trends and outliers while providing traditional line listings, descriptive statistics, and visual patient profiles. |
| CDASH (Clinical Data Acquisition Standards Harmonization) | CDASH is a CDISC standard that defines standardized data collection fields and structures for clinical trial data capture. CDASH is used to ensure that the CRF (Case Report Form) design aligns with downstream standards like SDTM, supporting consistency from data collection through submission. |
| CDISC (Clinical Data Interchange Standards Consortium) | CDISC is a global standards organization that develops the data standards for clinical research, including SDTM, ADaM, and CDASH. elluminate supports these standards to facilitate data mapping, validation, and regulatory submissions. |
| Clean Participant Tracker | Clean Participant Tracker is a Data Central feature that summarizes and monitors the overall data cleaning status across subjects, domains, issues, and queries to support review oversight and study-level data. |
| Clean Progress Tracking | Clean Progress Tracking is a Data Central feature that provides visibility into data review and cleaning progress. It consolidates review status, open issues, and open queries to help teams monitor completeness, spot bottlenecks, and evaluate overall data readiness. |
| Codelist | A terminology set associated with a specification, which is typically imported from a standard, and includes multiple values. |
| Cohort | A cohort is a specific group of subjects within a study who share a common feature, such as treatment assignment, enrollment phase, dose level, or study stage. Cohorts are observed as a group within elluminate. |
| Combo Chart | A Combo Chart displays two chart types, usually bars and lines, within one visualization to show multiple measurements together. Combo Charts allow comparison of related metrics and can use separate axes for each measure. They are created in Data Central Visualizations and are available in Analytics applications. |
| Comment | A space for ongoing dialogue about a record that can be made from multiple areas within the platform. Users can add multiple comments to a record, and each one is retained and viewable from various locations within elluminate. |
| Compound | A compound is the investigational product (e.g., drug or therapy) being studied in a clinical trial. In elluminate, compounds are configured at the study level and can be used for filtering, reporting, and analytics across modules. |
| Concomitant Medication (CM) | A Concomitant Medication (CM) is any medication a study subject takes before or during the trial that is not the investigational product. CM data is reviewed in Data Central listings and analyzed in dedicated Clinical Data Analytics (CDA) sheets. |
| Configuration | A process required so that elluminate can be utilized. Configuration can occur at the global level to apply to the entire platform, study level to apply to specific studies, and for user management. |
| Controlled Terminology | Controlled Terminology is a standardized set of predefined values used to ensure consistent coding and reporting of clinical data. In elluminate, Controlled Terminology is managed within the Standards module and applied in the Specifications module for mapping to align study data with selected standards such as SDTM. |
| Conversations | A dedicated area within the Help Center that enables elluminate users to connect, learn from each other, and share their experiences. |
| CRF (Case Report Form) | A CRF is the structured format used in a clinical trial to collect and organize raw subject data required by the study protocol during data entry. CRF data is entered into an EDC system and then imported into elluminate for review, transformation, validation, and analysis. |
| Critical Field | A Critical Field is a data field marked as especially important for review. In elluminate, fields labeled as Critical are visually highlighted in Data Central by a dark orange Critical icon (an octagon with an exclamation mark) in the column header of listings and in the field's Detail panel, to assist in prioritizing review. |
| CRO (Contract Research Organization) | CRO is an external organization contracted by a sponsor to conduct clinical trial activities such as data management, monitoring, and operational oversight. In elluminate, CRO users can be assigned user accounts, roles, or unlicensed user access to participate in study-level workflows and data review activities. |
| CSM (Centralized Statistical Monitoring) | A statistical scoring method within RBQM used for evaluating site-level risk with Key Risk Indicators (KRIs). When enabled, CSM provides additional configuration options that support statistical-based site scoring. |
| CTOA app (Clinical Trial Operational Analytics app) | An app within Analytics that provides an overview of operational data for studies, such as Enrollment, Query and Audit metrics, Adverse Event rates and Protocol Deviations. |
| CTQ (Critical to Quality Factor) | A Critical to Quality Factor (CTQ) is a key study-level risk category used in Risk Management to identify areas that could impact subject safety, data integrity, or outcomes. Each CTQ includes one or more considerations, which are structured questions that specify particular risk areas. Risks are then documented within RACT and monitored in RBQM. |
| Custom Listing | A Custom Listing is a user-defined data listing created in Data Central Visualizations from fields in one or more domains. Once saved, it functions like a standard listing for filtering, sorting, and exporting data. |
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| Dashboard | A Dashboard is a visual interface that shows key metrics and data through charts, table listings, and summaries to provide an at-a-glance view for monitoring, analysis, and decision-making within elluminate. |
| Data | Facts, statistics, or information collected as a part of a clinical trial that can be analyzed or used to make decisions. |
| Data Central | Data Central is the main data review module in elluminate, consolidating clinical and operational data for review. It also manages issues, queries, filtering, and oversight. Data Central functions as the primary workspace for tracking data completeness, quality, and review progress within a study. |
| Data Cut | A Data Cut is a specific subset of data in Data Central that uses a saved filter to limit the data scope for review. When applied, a Data Cut filters listings, metrics, and panels to focus on a specific population or time point, enabling targeted review and milestone-based data assessment. |
| Data Mart | A Data Mart is a data store within elluminate that contains mapped and transformed data, organized for reporting, analytics, and further use. It usually holds standardized or derived datasets created through mapping processes. |
| Data Quality Tool | The Data Quality Tool is a feature in elluminate that runs validation checks on study data to verify compliance with selected standards, such as SDTM, and to detect structural, formatting, or consistency issues before submission. |
| Data Review | Data Review involves examining study data to ensure accuracy, completeness, and consistency. In elluminate, this process is mainly carried out in Data Central, where users review records, create issues and queries, and track review progress. Data Review is also done in RBQM and Analytics to support risk-based monitoring and data analysis. |
| Data Sources | Data Sources are configured connections within elluminate that allow importing data from external systems into a study. These connections form the basis for automating the import and integration of clinical data. Once set up, import definitions can be created to fetch data on a scheduled or manual basis for ingestion, mapping, and review. |
| Data Store | A Data Store is a storage location within elluminate where study data is kept. A Staging Area is a data store that holds raw data as it is imported from source systems, while a Data Mart is a data store that contains mapped or transformed data prepared for reporting, analytics, and downstream use. |
| Data Variance | Data Variance is a feature in Data Central that lets users compare data over a specific date range to spot new, changed, or deleted records. Variance highlights help users focus on data updates since the previous review or data refresh. |
| Dataset | A dataset is a structured collection of data organized into rows and columns stored within an elluminate Data Store. It can originate from imported source data, mapped target domains, or programmatically generated outputs in SCE and is used for data review, validation, analysis, and reporting. |
| Define-XML | Define-XML is an XML-based metadata file that describes the structure, variables, controlled terminology, and derivations of clinical trial datasets submitted to regulatory authorities. It offers a machine-readable format of dataset definitions to assist regulatory review. |
| Details View | The Details View is a side panel in elluminate that shows complete information for a selected record. It lets users review field-level data, view comments, see history, and access related actions without leaving the current listing or dashboard. |
| DMOD (Data Model for Operational Data) | DMOD is an eClinical Solutions built-in standard data model designed for operational study data within elluminate. DMOD extends the Operational Data Repository structure and provides a standardized framework that can be selected in Mapping, managed in the Standards module, and used within Validator for operational data consistency and version control. |
| Domain | A Domain is a structured dataset within elluminate that contains related study data organized by subject or study activity. Domains typically represent a specific type of data (e.g., Adverse Events, Concomitant Medications) and are used for data review, analysis, and reporting. |
| Dynamic Dimension | A Dynamic Dimension is a configurable feature in Data Central Visualizations that allows users to switch between predefined dimension fields within a single chart. This provides flexible analysis by changing how data is grouped or displayed without altering the original visualization. |
| Dynamic Filter | A Dynamic Filter is a configurable filter option in Data Central Visualizations that lets users interactively filter chart data through predefined field selections. When activated, a filter control appears above the visualization, enabling users to refine results without changing the underlying chart setup. |
| Dynamic Mapping Template (DMT) | A Dynamic Mapping Template is a reusable mapping configuration in elluminate that automates converting source data into standardized domains. These templates reduce manual effort by applying predefined transformation logic across studies or data stores. |
| Dynamic Measure | A Dynamic Measure is a configurable feature in Data Central Visualizations that lets users switch between predefined numeric measures within a single chart. This enables flexible analysis by changing the displayed metric without altering the underlying visualization setup. |
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| EDC (Electronic Data Capture) | Electronic Data Capture (EDC) is a clinical data management system used to electronically collect, manage, and store clinical trial data at investigative sites. In elluminate, data from EDC systems is ingested for review, monitoring, and analysis. |
| eDrive | A file system within elluminate used to manage data, documents, and unstructured information. Both a global folder structure and study level folder structures are available. |
| eForms | A module within elluminate that allows users to enter, view, and edit non-clinical data through the use of custom-built web forms not otherwise imported into elluminate. |
| eIQ Review | eIQ Review is a feature within Data Central that uses machine learning models to detect potential data anomalies and inconsistencies. It shows flagged records for review and allows users to create issues and give feedback on model predictions directly within the interface. |
| elluminate® | elluminate is eClinical Solutions’ clinical data platform that combines data ingestion, mapping, review, analytics, and risk management features to support the management and analysis of clinical trial data. |
| elluminate Assist | elluminate Assist is a GenAI feature in Data Central that lets users ask natural language questions about study data. It generates SQL queries and creates results as a Custom Listing that can be opened, edited, and saved for further analysis. |
| ellumiNotes | Official release documentation for the elluminate platform that details new features, enhancements, resolved defects, and version-specific functionality included in each release. |
| Enrollment Rate | Enrollment Rate is a metric that measures how quickly subjects are enrolled in a study over a specific period. It is used to track recruitment progress and assess whether enrollment goals are being met. |
| ETL (Extract, Transform, Load) | ETL is the process used in elluminate to extract data from source systems, transform it as needed, and load it into a Data Store for review, mapping, and analysis. |
| Exception Listing | An Exception Listing is a Data Central listing set up to identify records that meet specific rule criteria or data conditions that need review. Exception Listings are often used to highlight potential data issues and support focused review workflows. |
| Exporter | The Exporter is an elluminate module used to export study data to formats such as Excel or delimited text for reporting or further processing. Users can perform one-time exports or save export definitions for consistent, repeatable results. |
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| Field | A Field is an individual data element within a domain that defines a specific variable, such as a date, number, or text entry. Fields store the values displayed in cells within listings and forms and represent the discrete variables that make up study datasets in elluminate. |
| Field Type | Field Type defines the format and data structure of a field, such as text, number, date, Yes/No, or picklist. It determines how data is entered, displayed, and validated within elluminate listings, forms, and configurations. |
| Filter | A Filter is a tool that limits the data displayed based on selected criteria. Filters enable users to narrow down results within listings, panels, or visualizations to focus on specific records, values, or subsets of study data. |
| Filter Panel | The Filter Panel is the left-side panel in Data Central that displays and manages filters. It enables users to view, clear, and organize Global Filters, Panel Filters, and Filter Sets all in one central location. |
| Filter Pill | A Filter Pill is a visual cue that shows an active filter in Data Central. Filter pills appear in the master header for Global Filters (including Data Cuts) and inside the Filter Panel for Panel and Visualization Filters. They display the selected filter criteria and let users quickly review or remove filters. |
| Filter Set | A Filter Set is a saved collection of applied filters in Data Central. It enables users to capture the current filtering state across dashboard panels and reuse that same data scope consistently across listings, panels, and visualizations. |
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| Global Data Store | A platform-level data repository in elluminate that supports shared data across studies or programs. It can be configured for use with Importer, Exporter, Tasks, Mapper, and optionally Analytics, with access controlled by compound, therapeutic area, or program associations. |
| Global Filter | A Global Filter is a filter in Data Central that affects all applicable listings, panels, and visualizations in the current workspace. When enabled, Global Filters show as filter pills in the master header and can be cleared or adjusted centrally. |
| Global Library | The Global Library is a centralized repository in elluminate that stores reusable configuration objects that can be promoted from or imported into studies. It supports the standardization and reuse of items such as Mapping Domains and Review Objectives across different studies. |
| Global-level | A product, module, configuration, feature, or view available for all studies or across the entire platform, based on user privileges. |
| Global PDAP | A Global PDAP is a reusable Protocol Deviation Assessment Plan defined within Metadata Management. Global PDAPs establish standardized deviation categories and other criteria that can be applied across multiple studies, encouraging consistency in classification. |
| Go Live | Go Live is the date when a new elluminate release or feature becomes available in production. It marks the official deployment of updated functionality before internal or client upgrade schedules. |
| GPP (Graphical Patient Profile) | A Graphical Patient Profile (GPP) is a visual display of a subject's data in Data Central, designed to support focused data review and exploratory analysis. |
| Granularity | Granularity refers to the level of detail at which data are viewed or analyzed, such as study-level, country-level, site-level, or subject-level. It determines how data are grouped or summarized in listings, dashboards, and visualizations. |
| Groups (User Groups) | Groups are collections of users in elluminate who share the same assigned privileges and access settings. Groups make user management easier by handling permissions at the group level rather than for each individual. |
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| Hard-coded Schema | A Hard-coded Schema is a configuration in Mapper in which a specific data store schema name is set directly in the mapping logic instead of being referenced dynamically via a token. Hard-coded schemas reduce the mapping domain's reusability across studies or environments because the schema reference does not update automatically. |
| Help Center | The Help Center is elluminate’s online knowledge base that provides user documentation, configuration guidance, release notes (ellumiNotes), training resources, and product announcements to support platform use and adoption. |
| High-Level Term | A High-Level Term is a grouping level within the MedDRA hierarchy that organizes related Preferred Terms under a broader medical concept. High-Level terms are used in analysis and reporting to summarize adverse event data at an intermediate level of detail. |
| High-Level Group Term | A High-Level Group Term is a broader category within the MedDRA hierarchy that groups related High-Level Terms under a common medical classification. High-Level Group Terms enable higher-level summarization and analysis of adverse event data. |
| Histogram Chart | A Histogram is a visualization that shows the distribution of numeric data by grouping values into intervals (bins) and displaying how often values occur in each bin. Histograms are created in Data Central Visualizations to analyze data patterns and spot trends or outliers. |
| Home Page | The Home Page is the primary landing page in most modules within elluminate. It provides access points to the module's features. Each Analytics App also has a Home Page that displays high-level study metrics. |
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| IDRP (Integrated Data Review Plan) | The Integrated Data Review Plan (IDRP) is a structured framework within Data Central that outlines, manages, and tracks study-level data review objectives. IDRP links review objectives to RACT risks and materials like Data Listings and Orchestrator Rules, allowing for centralized oversight and review of approval workflows and performance. |
| Importer | Importer is the elluminate module used to bring external study data into a staging area or data mart. Imports can be executed manually or according to a scheduled plan. Importer supports a variety of popular data formats. |
| Insight Advisor (Analytics) | Insight Advisor is a guided analytics feature within Analytics that enables users to explore data by generating recommended visualizations based on selected fields and search queries. It helps users identify patterns and insights without manually creating charts. |
| Investigational Product | An Investigational Product refers to the drug, biologic, device, or therapy being tested in a clinical study. In elluminate, Investigational Product information can be configured at the study level and used for reporting, analytics, and risk management. |
| Issue | An issue is an internal, tracked question, discrepancy, or action item created against a record or configuration object within elluminate. Issues are managed within the platform and are distinct from EDC queries. |
| Issues | Issues is the centralized module where all created Issues can be viewed, managed, and actioned across the platform. |
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| Join | A Join is an operation that combines data from two or more tables based on matching fields. In elluminate, joins are defined in Mapper, can be used in Custom Listings, may be generated through elluminate Assist, and are supported in Specifications for defining source-to-target relationships. |
| Join Key | A Join Key is the field or set of fields used to match records between tables during a join. Join Keys define the relationship between datasets and determine how rows are merged in the join operation. |
| JSON (JavaScript Object Notation) | JSON is a lightweight, text-based data format used for structuring and transferring data between systems. In elluminate, JSON is primarily used internally for system integrations, configuration objects, and structured data exchanges rather than as a user-managed configuration file. |
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| Key (ETL Key) | An ETL Key is a specific field or set of fields used during the Extract, Transform, Load process to uniquely identify records within a dataset. ETL Keys enable change tracking, data comparison, and record review by maintaining consistent data identification across imports. |
| KRI (Key Risk Indicator) | KRI is a quantifiable monitoring metric used in RBQM to track risks at the site, country, or study level and support ongoing risk-based oversight and intervention. |
| KRI Score | A KRI Score is a numerical value assigned to a Key Risk Indicator based on established thresholds and performance standards. The score indicates the current risk level for the metric. |
| KRI Threshold | A KRI Threshold defines the preset limits or ranges used to evaluate a KRI’s performance. Thresholds determine how a KRI is categorized (e.g., low, medium, high risk) and affect the resulting KRI Score. |
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| Last Data Refresh | Last Data Refresh is the most recent date and time when data in a listing, dashboard, or data store was updated through an import or data load process. It shows when the displayed data was last synchronized with its source system. |
| Learning Portal | The Learning Portal is an online training resource that provides structured learning content and educational materials to support effective use of the elluminate platform. |
| Left Navigation | Left Navigation is the collapsible menu panel in elluminate that provides access to modules, listings, dashboards, and configuration areas within the platform. It allows users to navigate between workspace areas and study components. |
| Library Object | A Library Object is a reusable configuration item stored within a library in elluminate, such as the Global Library or Risk Management Configuration. Library Objects help standardize and reuse configuration elements across studies or risk assessments. |
| Listing | A Listing is a tabular view of structured data in elluminate, showing records in rows and columns. Listings support filtering, sorting, exporting, record-level actions, and field-level actions such as creating issues or queries on individual cells. |
| Listing and Details View | The Listing and Details View layout displays a data listing alongside the Details View. This side-by-side layout lets users see complete record details while keeping the listing visible. |
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| Mapper | Mapper is the elluminate module that transforms and standardizes data by defining mapping logic between source and target domains. It supports joins and other transformation functions to prepare data for use in Data Marts, reporting, and analysis. |
| Mapping | A Mapping is the overall transformation configuration within Mapper that defines how source data is extracted, joined, derived, standardized, and loaded into one or more target datasets. It represents the complete set of transformation logic used during data processing. |
| Mapping Automation | Mapping Automation is an elluminate feature that speeds up data mapping by using predefined logic and automation to match source data with target domains. It decreases manual effort and helps prepare standardized datasets more quickly for analysis and reporting. |
| Mapping Domain | A Mapping Domain is a specific target dataset defined within a Mapping. It details the structure and fields of the output dataset and includes the field-level transformation logic used to create that specific domain. |
| Mapping Function | A Mapping Function is a defined transformation rule, implemented as executable logic, that runs during the mapping process to transform or derive field values from source data. Mapping Functions perform calculations, string operations, aggregations, conditional logic, and other data transformations to produce standardized output fields. |
| Master Header | The Master Header is the top navigation bar in elluminate that provides access to study selection, global filters, search, notifications, user settings, and other high-level controls. It remains visible across modules and ensures consistent navigation and context throughout the platform. |
| Metadata | Metadata is the structured information in elluminate that defines data properties, including domains, fields, labels, data types, controlled terminology, and attributes. Metadata governs how data is interpreted, displayed, and used across the platform. |
| Metadata Editor | Metadata Editor is a user privilege that allows configuring and editing metadata settings within the Metadata module. Users with this privilege can modify field properties, assign attributes such as Critical status, and manage domain-level metadata definitions. |
| Metrics | Metrics are calculated values derived from study data that measure performance, progress, quality, or risk within elluminate. These metrics are shown in Data Central, Analytics, Operational Oversight, and Risk Management to support monitoring, review, and decision-making. |
| Model (eIQ Model) | In the context of eIQ Review, a Model is a machine learning algorithm created to detect potential data anomalies, inconsistencies, or risk patterns within study data. Each model examines specific data areas and flags records for review based on predefined detection logic. |
| Module | A Module is a key functional area within elluminate that offers distinct capabilities, such as Data Central, Analytics, Risk Management, Mapper, or the Statistical Computing Environment. Large feature sets like Data Central are also called products and support particular functionalities within the platform. |
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| Notification | A Notification is an automated alert in elluminate that informs users about specific events, such as completed executions, assigned issues, review submissions, approvals, or other system-triggered activities. Notifications appear in the master header for the currently logged-in user and can also be sent via email, depending on the configuration. |
| Null | Null indicates that a data value is unknown or missing. In elluminate, a Null value displays as an empty field or cell. |
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| Operational Data Repository (ODR) | The Operational Data Repository is an elluminate module that stores and manages structured operational study data. This includes studies, sites, investigators, milestones, protocol deviations, and related operational records used for reporting, analytics, and risk management workflows. |
| Operational Oversight (OO) | Operational Oversight is an analytics app in elluminate that offers dashboards and visualizations of operational study data stored in the ODR. The app supports monitoring study performance, enrollment, milestones, and site-level metrics. |
| Orchestrator | Orchestrator is an elluminate module that allows configuring and executing rule-based logic on study data. It automatically generates and handles issues and queries according to specified rule conditions. |
| Orchestrator Rule | An Orchestrator Rule is a configurable rule within the Orchestrator module that defines condition-based logic. The rule evaluates study data and automatically creates or updates issues and queries when the specified condition is met. |
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| Panel | A Panel is a configurable section within a workspace that displays a listing, visualization, or dashboard component, supporting filtering, sorting, and user interaction. |
| Panel Filters | Panel Filters are filters applied to a specific panel within a workspace. When filtering a panel, use the Filter Rows or Filter to Selected Records option to affect only the selected panel. When using the Filter Subjects option, the filter applies to all panels in the workspace for the selected subject(s). |
| Personas | Personas are predefined user archetypes in elluminate that represent common roles and responsibilities. Examples include Clinical Data Manager, Clinical Data Reviewer, Risk Manager, Study Lead, Statistical Programmer, and System Administrator. |
| Picklist | A Picklist is a field type that allows selecting a value from a predefined list. |
| Pie Chart | A Pie Chart is a type of visualization that displays categorical data as slices of a circle, with each slice representing a proportion of the total value. |
| Pinnacle 21 Enterprise | Pinnacle 21 Enterprise is an external clinical data validation system that integrates with elluminate to perform data quality and compliance checks against CDISC standards such as SDTM and ADaM using the Data Quality Tool. |
| Pivot Table | A Pivot Table is a tabular visualization that summarizes and aggregates data by organizing values across rows and columns, enabling grouping, comparison, and drill-down analysis. |
| Platform Administration | A section within the elluminate Platform Menu that provides administrators with access to key system management tools, including user management, URL configuration, system reports, audit logs, data imports / exports, and other administrative features. |
| Platform Menu | The Platform Menu, accessed via the 9-dot icon in the master header, provides links to elluminate modules and various functional areas throughout the application. |
| Primary Domain (IDRP) | The Primary Domain is the main clinical data domain associated with a Review Objective in the Integrated Data Review Plan. It determines how the Review Objective is organized and displayed in the Review Plan and Dashboard views within Data Central. |
| Privilege | A privilege is a permission granted to a user or user group that controls access to specific modules, functions, configuration areas, or actions within elluminate. |
| Product | A product is a large module within elluminate that provides a specific set of capabilities, such as Data Central, Analytics apps, Operational Data Repository, Risk Management, or Statistical Computing Environment. |
| Program | A program is a higher-level grouping in elluminate used to organize and manage multiple related studies within a common therapeutic area, compound, or clinical initiative. |
| Promote to Global Library | Promote to Global Library is an option that copies a study-level Mapping Domain or approved Review Objective into the Global Library for reuse across studies. |
| Protocol Deviations | Protocol Deviations are documented instances where study conduct does not adhere to the approved study protocol. These can include deviations related to eligibility criteria, visit timing, procedures, dosing, or other protocol requirements. In elluminate, Protocol Deviations are recorded, categorized, reviewed, and tracked within the Protocol Deviations Dashboard in Data Central. |
| Protocol Deviation Assessment Plan (PDAP) | A Protocol Deviation Assessment Plan (PDAP) is a set of guidelines used to categorize and review protocol deviations in elluminate. It explains how deviations are organized, their significance, and how they should be evaluated within a study. |
| Protocol Deviations Dashboard | The Protocol Deviations Dashboard serves as the central interface in Data Central where protocol deviations are created, viewed, reviewed, edited, and monitored. It offers summary metrics, filtering options, review status tracking, and links to related PDAP standards, enabling oversight and analysis of protocol deviations within a study. |
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| Query | A Query is a concern or question raised on a specific data point. They can be created in Data Central or imported from an external EDC system and managed within elluminate. When configured with a bi-directional EDC connection, query actions can be synchronized between elluminate and the source system. |
| QTL (Quality Tolerance Limits) | A QTL is a predefined study-level limit applied to a CTQ that falls outside the acceptable performance range. Exceeding a QTL indicates a potential systemic quality issue that requires formal assessment. |
| QTL Threshold | QTL Threshold is the defined numeric or percentage limit set for a Quality Tolerance Limit that determines when a study-level metric exceeds the acceptable range and prompts evaluation or escalation. |
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| RACT (Risk Assessment and Categorization Tool) | RACT is elluminate’s module for identifying, assessing, categorizing, and documenting study-level risks. It enables structured risk evaluation with customizable scoring, supports mitigation and monitoring plans, and maintains version-controlled assessments that comply with regulatory guidance. |
| Rave EDC | Rave EDC is an external Electronic Data Capture system that connects with elluminate to allow importing, syncing, and managing clinical trial data and queries across the elluminate platform. |
| RBQM (Risk-Based Quality Management) | RBQM is elluminate's module for monitoring and managing study risks through centralized data review and key risk indicators. It applies risks identified in RACT by tracking thresholds, generating alerts, and supporting oversight at the study, country, and site levels to ensure quality and compliance. |
| Related Query | A Related Query is linked to a specific issue or record in elluminate. It provides traceability between the identified data discrepancy and the formal query raised in the source system. This allows users to navigate between the issue and its related query for review and tracking. |
| Reporting Database | The Reporting Database is an optional feature that provides secure external access to specific study data stored within elluminate. It enables the study's data to be transferred to approved external database environments (such as Snowflake or AWS RDS) for querying and reporting. This supports downstream analytics, integration, and regulatory reporting outside of elluminate. |
| Reports (Module) | Reports is the elluminate module used to generate and manage predefined system and audit reports. It provides access to structured reports such as user activity logs, query audit history, and analytics review logs, supporting oversight, compliance, and traceability across the URL. |
| Review Objective | A Review Objective is a clear, measurable task in the Integrated Data Review Plan (IDRP). It specifies the data or materials to be reviewed, the reviewer's role, how often the review occurs, and the priority level, thereby documenting study-level data review tasks. |
| Review Plan | The Review Plan is a structured process within elluminate’s Integrated Data Review Plan (IDRP) that organizes, manages, and tracks study-level data review tasks. It includes configured Review Objectives linked to specific data listings, analytics, rules, or risks. This setup enables oversight of review progress, completion status, and accountability for reviewer roles. |
| Reviewer Roles | Reviewer Roles are study-level roles in Data Central that determine which users are responsible for reviewing specific domains, review objectives, or data listings. Reviewer Roles influence review visibility, track completion, and compile review metrics. |
| Risk | A Risk is an object within RACT that indicates a possible study-level issue that could impact quality, safety, data integrity, or compliance. Risks include, but are not limited to, attributes such as category, CTQ, risk statement, risk score, mitigations, and monitoring strategy. The risks are evaluated and monitored through a RACT Assessment. |
| Risk Management | Risk Management is the elluminate module used to identify, assess, monitor, and document study risks. It provides access and integrates RACT and RBQM to support structured risk assessment, ongoing risk monitoring, and oversight of risk-related actions throughout the study lifecycle. |
| Role | In elluminate, a Role is a configurable assignment within a study or module that defines user responsibilities, workflow participation, and functions like review, approval, monitoring, execution, or notification eligibility. |
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| Scatter Bubble Chart | A Scatter Bubble Chart is a chart in Data Central Visualizations that plots data points on two numeric axes and uses a third numeric measure to determine the size of each bubble. Scatter Bubble Charts can be created in Data Central Visualizations and viewed across Data Central workspaces, Analytics apps, and other dashboards in elluminate. |
| SCE (Statistical Computing Environment) | The Statistical Computing Environment (SCE) is an elluminate module that offers a platform for developing and executing SAS, R, and Python programs that apply study-specific logic to data within elluminate. The SCE facilitates the transformation, analysis, and creation of study datasets while supporting controlled development, versioning, and auditability of programs and outputs. |
| Schema Prefix | Schema Prefix is a token-based reference in Mapper that dynamically represents the underlying database schema linked with a Data Store. Schema Prefix replaces hard-coded schema names and serves as a placeholder for source table definitions, enabling mappings to migrate across studies or environments. (e.g., ${SchemaPrefix}.AE) |
| SDTM (Study Data Tabulation Model) | SDTM is a CDISC standard that defines the structure, domains, variables, and metadata required for clinical trial data. It arranges study data into a consistent tabular format for regulatory submissions. |
| Secondary Domain (IDRP) | The Secondary Domain is an additional clinical data domain linked to a Review Objective in the Integrated Data Review Plan. It facilitates cross-domain review and analysis but does not determine grouping or primary display rules within the Review Plan Dashboard. |
| Sheet (Analytics) | A Sheet is a page in an Analytics app that contains interactive visualizations, filters, and tables organized to support analysis of a specific subject area or metric in elluminate. |
| Sheet (Data Central) | A Sheet is a component of a Data Central workspace that contains organized panels such as listings and visualizations. Sheets display as tabs at the bottom of the workspace and allow users to switch between views. |
| Site | The site is a location involved in a clinical trial where subjects are enrolled, and study activities are carried out under the supervision of investigators and staff. |
| Skip Missing | Skip Missing is a Mapper table-level property that allows a mapping to continue when a source variable or source domain is absent. When activated, missing variables or domains are substituted with blank values instead of causing the mapping to fail. |
| Snapshots | Snapshots are time-based captures of data, listings, or visualizations. There are two types of snapshots in elluminate. Study Snapshots record study data at a specific point in time for later review and export. Analytics Snapshots save a sheet at a specific point in time for reuse in Stories and reports. |
| Source Table | The Source Table is the input table used in Mapper or Specifications, containing the original data fields selected for transformation into a Target Domain. |
| Specifications | Specifications is an elluminate module used to define how source data is transformed into a target standard. Specifications apply Standards by mapping source variables to standardized domains and variables, defining transformation logic, assigning codelists, and documenting derivations required to conform data to the selected standard. |
| SQL (Structured Query Language) | SQL is a widely used, common language for querying, transforming, and managing data in relational databases. In elluminate, SQL is integrated into modules like Mapper, Specifications, Advanced Filters, and Orchestrator to define data selection, transformation, filtering, and logic. Not all users need to know SQL, as elluminate automatically generates SQL through configuration interfaces and visual tools for those who don't write SQL manually. |
| SQL Token | In elluminate, SQL Tokens are predefined placeholders in SQL expressions that dynamically reference elements such as schema names, studies, or system variables. SQL Tokens allow for reusable and portable logic across studies, environments, and mapping configurations without hardcoding specific values. |
| Staging Areas | The Staging Area is a data store within elluminate that holds imported source data before transformation or mapping. It functions as the raw data layer for downstream processing. |
| Standards | Standards is an elluminate module used to manage and browse industry-defined data models and controlled terminology, including CDISC standards such as CDASH, SDTM, and ADaM, as well as imported custom standards. This module also defines the required structure, variables, and permissible values for standardized clinical datasets. |
| Stories (Analytics) | Stories are narrative presentations in Analytics that combine visualizations, text, and snapshots to clearly communicate insights, findings, and key metrics. |
| Study | A study in elluminate represents a single clinical trial and serves as the container for data, modules, mappings, review settings, risk management configurations, analytics, and workflows related to a specific protocol. |
| Study-level | Study-level refers to configuration, data, settings, or functionality that applies specifically to a single Study and does not extend across other studies or the entire elluminate platform. |
| Study Card | Study Card is a visual summary tile shown in modules like Studies, Operational Data Repository, Operational Oversight, and Risk Management. It displays key study information, status indicators, alerts, and metrics. Study Cards offer quick visibility into study status and performance. |
| Study PDAP | A Study PDAP is set up at the individual study level within Data Central Configuration. Study PDAPs can be imported from Global PDAPs or created specifically for the study. Study PDAPs are used to classify and assess protocol deviations recorded within that study. |
| Subject | A Subject is an individual participant enrolled in a Study whose clinical, operational, and safety data are collected, reviewed, and managed within elluminate. |
| Subjects Listing | Subjects Listing is the Data Central panel that displays all Subjects within a Study and provides visibility into subject-level review status, open issues, open queries, and related metrics. |
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| Tags | Tags are globally configured labels in Metadata that can be assigned to domains, data stores, and other supported objects. Tags help with organizing, grouping, filtering, and managing related elements across elluminate. |
| Target Domain | The Target Domain is the destination domain where data is written as the result of an import, mapping, or logic execution in SCE. It represents the structure that receives transformed data. |
| Tasks | Tasks is an elluminate module that enables configuration, scheduling, and automation of platform and study activities such as data imports, exports, mapping runs, validation jobs, and program execution. A Task is a defined automation object that specifies the action to perform, the execution timing, and the associated run settings for a workflow. |
| Templates | Templates are reusable objects in elluminate that store predefined settings and logic for consistent use across studies, including Study Templates, Dynamic Mapping Templates, Import Templates, and validation configurations. |
| Therapeutic Area | Therapeutic Area is a clinical classification that organizes studies, programs, and compounds by the disease or medical condition being studied. |
| Timeline Chart | The Timeline Chart is a visualization type in Data Central Visualizations that displays events or data points along a time axis to show duration, sequence, and timing relationships for subjects or records within a study. |
| Total Risk Score | The Total Risk Score is the value assigned to a Risk in a RACT assessment, calculated based on factors like impact and likelihood. The score indicates the overall risk level and helps determine risk categories and priorities. |
| Transformation | Transformation is the logic defined in Mapper that converts source data into a Target Domain by applying mapping rules, calculations, derivations, joins, or other data manipulation methods. |
| Treatment Arm | A Treatment Arm is a specific group within a Study that assigns subjects to a particular intervention, regimen, or control condition based on the study protocol. For example, a study might include one arm receiving Drug A, another receiving Drug B, and a third receiving a placebo. |
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| Union | Union is a Mapper operation that merges rows from two or more source tables or domains with identical column structures into a single output dataset. Unions allow data consolidation across similar domains, supporting dynamic unions with wildcard patterns. |
| Unlicensed Users | An Unlicensed User is a type of user account created for third-party individuals, such as CRO or central lab staff, who require limited access to elluminate. Unlicensed Users can receive and reply to assigned Issues, but do not have full access to modules or the platform's broader features. |
| Unmitigated Risk | Unmitigated Risk is a risk identified in a RACT assessment where no mitigation strategy or control has been defined or put into place. This risk indicates a potential issue that remains unaddressed and may need action to lower its impact or likelihood. |
| URL | A URL is a distinct elluminate environment that has its own configuration, studies, users, data sources, and module settings. Each URL operates independently and can represent a development, validation, or production instance. |
| URL Setting | URL Settings are system-wide configuration options that apply to all studies within a specific elluminate URL. URL Settings manage global functions like authentication, module activation, integration setup, and platform-level settings. |
| User | A User is an individual account within elluminate that is assigned privileges and roles to access modules, data, and functionality. |
| User Profile | The User Profile account page in elluminate can be accessed from the Platform Menu. This page displays user preferences, assigned privileges, roles, study access, API credentials, and related settings. |
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| Validation Definitions | A Validation Definition is a set of configured validation rules in elluminate that outlines the standards, domains, scope, and rule selections. It is used to evaluate study data for compliance with selected standards such as SDTM or ADaM. |
| Validation Rule | Validation Rules are specific rules within a Validation Definition that assess particular data elements against established structural, formatting, or standards-based criteria to identify compliance issues in study data. |
| Variable | A variable is a defined data field within a domain that represents a specific data element collected, mapped, or derived in elluminate. In tabular format, variables are the columns. They are configured in Standards and Specifications and are used in Mapper, Data Central, Analytics, and validation processes to store and transform study data. |
| Veeva CDMS | Veeva CDMS is an external Clinical Data Management System that integrates with elluminate. This allows for importing, synchronizing, and managing clinical data and queries from Veeva EDC within elluminate. |
| Visualization | A visualization is a graphical display of study data, such as a bar chart, line graph, pie chart, scatter plot, or timeline, used to analyze and interpret data in elluminate. Visualizations are present throughout elluminate and can be created in Data Central Visualizations for viewing in Data Central workspaces. Analytics apps feature interactive visualizations on sheets, and custom Analytics sheets can be created to support additional analysis. |
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| Web Services (Outbound) | elluminate's Web Services is an outbound RESTful API that transmits data from elluminate to an external system through a configured API connection, enabling automated downstream data transfer. |
| Work Datasets (SCE) | Work Datasets are temporary datasets created during the execution of SAS, R, or Python programs in the SCE. They reside in the session work library and can optionally be returned to the SCE after program completion. |
| Work Libraries (SCE) | Work Libraries are temporary storage libraries in the Statistical Computing Environment used during SAS program execution to hold intermediate datasets and processing outputs for the current session. |
| Workspace | A Workspace is a customizable layout within Data Central that organizes and displays data for a study. It can include one or more Sheets, which appear as tabs at the bottom of the workspace. Each sheet can be set up with listings, visualizations, and other panels to support structured data review and analysis. |
| Workspace Settings | Workspace Settings are configuration options that define how a Workspace operates and looks, including preferences like default layouts, filter behavior, and role-based defaults. |
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| X-axis | The X Axis is the horizontal axis in a visualization that represents the independent data dimension, such as time, category, or grouping variable, used to organize values displayed in charts within elluminate. |
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| Y-axis | The Y Axis is the vertical line in a visualization that displays the measured value or numeric scale in charts within elluminate. The Y Axis indicates the magnitude of data points plotted against the X Axis. |
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| Z-Score | The Z Score is a statistical measure displayed on RBQM dashboards that shows how much a site-level metric differs from the study average. It helps identify outliers and guides risk-based monitoring decisions. |