Important: Products and Modules are privilege based, therefore you may not have access to all of them.
Products
| PRODUCT | EXPLANATION |
|---|---|
| Analytics | Analytics provides a visual and interactive display of your study’s data, allowing authorized users to perform robust in-study and cross-trial reporting and analysis. Includes the CDA, CTOA, Sample Management Analytics, and Operational Oversight Analytics apps. |
| Data Central | Data Central is used to review, query, and clean study data imported into elluminate. |
| eIQ Review | eIQ Review is AI-enabled data review that conducts assisted data review within Data Central for a less time-consuming and more scalable review approach. There are several models available. |
| Mapper | Mapper is used to modify the data structure or format for the purposes of standardizing and reporting data in a low code environment. |
|
Operational Data Repository (ODR) (formerly CTMS Insights) |
Operational Data Repository (ODR) is used to ingest or manually add operational data into elluminate. Data are imported or added to the Operational Data Repository (formerly CTMS Insights) module. Part of Operational Insights. |
|
(formerly the CTMS Insights app) |
Operational Oversight is an app within Analytics that provides a dashboard view of operational data. Part of Operational Insights. |
| Protocol Deviations | Protocol Deviations simplifies the management of protocol deviations by offering user-friendly interfaces for configuring Global and Study Protocol Deviation Assessment Plans (PDAPs). It allows users to apply these standards and assign review statuses, while also providing access to Protocol Deviation data in Data Central. This enhances oversight and compliance in clinical studies. |
| Risk Management | Risk Management embeds RACT and RBQM in elluminate to operationalize ICH E6(R3). RACT identifies and assesses risks to critical data and processes, while RBQM drives targeted, data-driven oversight and documented actions during study execution. Together, they enable continuous, inspection-ready risk management aligned with regulatory expectations. |
| SCE | The Statistical Computing Environment (SCE) provides a validated environment for data processing and statistical analysis using SAS, R, and Python code. Users can develop and maintain programs and macros, and execute those programs against data within the elluminate Clinical Data Cloud. SCE allows for the production of submission or exploratory analysis outputs - within and across studies - in a way that is transparent, auditable, reproducible, and secure. |
Modules
| MODULE | EXPLANATION |
|---|---|
| Audit Logs | Audit Logs are used to review all additions / modifications / deletions of study related data. As a typical user, you will only be able to see your actions within elluminate. Administrators can see the actions of all users. |
| Data Quality | Data Quality is used to validate the structures of the data that have been integrated into elluminate using Pinnacle 21 Validator. You may have access to the Validator module instead. |
| Data Sources | Data Sources are used to define the access to the data you will be importing into elluminate. |
| Define-XML | Define-XML is used to create a Define-XML file from a specification. |
| eDrive | eDrive is used as the elluminate file system to manage data, documents, and unstructured source data for a study. |
| eForms | eForms is used to enter data into elluminate that is not being imported into elluminate. For example, you might have data that you want to integrate, but is not part of the EDC forms. |
| Orchestrator | Orchestrator is designed to facilitate data import and review processes by allowing users to create basic conditional rules. Orchestrator automatically identifies records that meet these established rules and creates Issues on the specified fields, as well as closes Issues for records that are no longer flagged by the rules, aiding in efficient and more accurate clinical data management. It features a user-friendly rule management interface, an easy-to-follow rule creation process, and a dual condition-building experience. Users have the option to include automatic opening and closing of Queries along with the default Issues generation. |
| Exporter | Exporter is used to export the data from elluminate. Here you can export out entire domains to various formats. |
| Global Library | The Global Library allows users to view and manage objects in the Global Library through a dedicated page. The page supports searching and filtering. Users with the Global Library Configure privilege can manage Global Library objects, including editing, approving, and making objects visible for importing into studies. Objects can be promoted from Mapper and from the Review Objectives list in the Integrated Data Review Plan to the Global Library. Objects can be imported from the Global Library into a mapping and into the list of review objectives in the Integrated Data Review Plan. |
| Importer | Importer is used to import study data into elluminate. This is the first step after a study has been defined. If data have not been imported into a study, there will not be data available in the study. Within the Importer module, you can import both clinical and operational data. |
| Issues | Issues is used to communicate and resolve problems, issues, inconsistencies, questions, etc. created throughout the Platform. |
| Metadata | Metadata is used to analyze the metadata associated with the data that have been integrated into elluminate, ensuring the data are in the expected structures. |
| RACT | The Risk Assessment and Categorization Tool (RACT) is used to support risk identification, assessment, categorization and review. The RACT includes the ability to manage a global library of risk assessment questions, maintain study-specific study risk tools and review all of the risk assessments conducted within elluminate. |
| RBQM | Risk Based Quality Management (RBQM) provides the ability to monitor sites in an ongoing study, reducing risks in clinical development without compromising patient safety or data quality. |
| Snapshots | Snapshots are used to capture the data at the current point in time. This data can be accessed at a later time from Exporter or within the Visualizations (Analytics). |
| Specifications | Specifications is a tool for authoring, viewing, and managing specifications for dataset mapping or exception listings for each study. |
| Standards | Standards is used to browse through the CDISC Standards, including CDASH, SDTM, and ADaM. This enables users to find details on a standard without having to leave elluminate. In addition, you can export the standards documents, as well as import customized standards. |
| Tasks | Tasks are used to schedule certain activities to happen at a set time for your study, such as imports, exports, and / or data quality validations. You can also schedule an email to be sent to you notifying you of the status of the task. |
| Validator | Validator is used to validate the structures of the data that have been integrated into elluminate. |