Audit Logs displays additions, modifications, and deletions to study data. Standard users can view their own actions in elluminate. Administrators can view the actions of all users.
Tasks schedules study activities, such as imports, exports, and data quality validations. Email notifications can also be scheduled to report the status of a task.
Analytics provides visual and interactive displays of study data that support in-study and cross-trial reporting and analysis for authorized users. Analytics includes the Clinical Data Analytics (CDA), Clinical Trial Operational Analytics (CTOA), Sample Management Analytics (SMA), and Operational Oversight (OO) Analytics components applications.
Data Quality validates the structure of data integrated into elluminate using Pinnacle 21 Validator. Access may be provided through the Validator module instead.
Global Library allows users to view and manage Global Library objects through a dedicated page that supports searching and filtering. Users with the Global Library Configure privilege can manage Global Library objects, including editing, approving, and making objects visible for import into studies. Objects can be promoted from Mapper and the Review Objectives list in the Integrated Data Review Plan to the Global Library. Objects can also be imported from the Global Library into a mapping and the Review Objectives list in the Integrated Data Review Plan.
eForms is used to enter data into elluminate that is not otherwise imported into elluminate, including data that is not collected through Electronic Data Capture (EDC) forms.
SCE provides a validated environment for data processing and statistical analysis using SAS, R, and Python. Users can develop, maintain, and execute programs and macros against data within the elluminate Clinical Data Cloud. SCE supports the production of submission and exploratory analysis outputs within and across studies in a transparent, auditable, reproducible, and secure environment.
Data Central reviews, queries, and cleans study data imported into elluminate. It also provides access to the Integrated Data Review Plan (IDRP) for review planning and execution.
Orchestrator facilitates data import and review by allowing users to create basic conditional rules. It identifies records that meet the defined rules, creates Issues on the specified fields, and closes Issues for records that no longer meet the rules. Orchestrator includes rule management, a dual condition-building experience, and the option to automatically open and close Queries in addition to the default Issues generation
Protocol Deviations manages protocol deviations by providing interfaces for configuring Global and Study Protocol Deviation Assessment Plans (PDAPs). It supports the application of these standards, assignment of review statuses, and access to Protocol Deviation data in Data Central for study oversight and compliance.
ODR ingests or allows manual entry of operational data into elluminate. Data are imported or added to the Operational Data Repository module. ODR is part of Operational Insights.
Operational Oversight is a component within Analytics that provides a dashboard view of operational data. Operational Oversight is part of Operational Insights.
RACT supports risk identification, assessment, categorization, and review. RACT includes the ability to manage a global library of risk assessment questions, maintain study-specific risk tools, and review risk assessments conducted within elluminate.
Risk Management embeds RACT and RBQM in elluminate to operationalize ICH E6(R3) Good Clinical Practice (GCP) guidelines. RACT identifies and assesses risks to critical data and processes, while RBQM supports targeted, data-driven oversight and documented actions during study execution. Together, they support continuous, inspection-ready risk management aligned with regulatory expectations.