Introduction to Standards
Standards provide a consistent framework for how clinical trial data are structured, named, and organized. They promote alignment across study sites, data management teams, researchers, and regulatory bodies by ensuring that data can be collected, submitted, analyzed, and reviewed in a standardized way.
The Standards module in elluminate supports both industry-defined standards and custom models to facilitate seamless data management across clinical systems.
Supported CDISC Standards
The Clinical Data Interchange Standards Consortium (CDISC) defines widely adopted data standards for clinical research. These standards cover the full lifecycle of clinical data—from initial data capture to analysis-ready datasets:
- Clinical Data Acquisition Standards Harmonization (CDASH): Defines standardized fields for collecting clinical data.
- Study Data Tabulation Model (SDTM): Specifies how trial data should be organized for regulatory submission and reporting.
- Analysis Data Model (ADaM): Provides structure for datasets used in statistical analysis.
Users can browse and search these CDISC standards directly within the module, eliminating the need to reference external systems. Custom standards can also be manually uploaded or imported (synchronized) with an MDR system.
DMOD: Data Model for Operational Data
In addition to industry standards, eClinical Solutions provides DMOD (Data Model for Operational Data)—a proprietary standard designed to streamline the management and analysis of operational data in clinical trials.
DMOD offers a consistent and comprehensive data structure that simplifies the ingestion, transformation, and analysis of operational data from diverse sources. It serves as the foundational source data layer for analytics and clinical trial oversight. Built on the original Operational Data Repository (ODR) structure, DMOD has been significantly enhanced to provide broader coverage of operational data elements critical to effective study execution.
Using Standards in Other elluminate Modules
Standards can be leveraged across multiple elluminate modules to enhance consistency and data quality:
- Mapper: Assists with mapping to defined standards, helping ensure consistency and preventing mapping errors.
- Validator: Enables automated validation to check data conformance against selected standards.
- Specifications: Serves as a foundational reference when building study specifications. Only CDISC standards (CDASH, STDM, and ADaM) are supported in this module; DMOD is not supported.
Access Standards
- Access Standards from the Platform Menu under Metadata Management. Available standards are listed on the left side of the window, referred to as the Standards tree.
Click a Standard (e.g., SDTM 3.3) to display details for the selected version. The Standard type and version are shown in the upper-left corner of the window.
- Click any link within the main window to drill down and view additional information. Drill-down is available for fields such as Observation Class, Domain Name, Code List, Data Structure Name, and Dataset Name, depending on the Standard being browsed. In the example shown, the Domain Name column has active links to more detailed information.
To explore further, drill down on a domain name and look up the Code List for a specific variable. In the example shown below, SDTM version 3.3 is displayed, showing the CM domain and information about the Code List for NY on the variable CM Occurrence, with Controlled Terminology Version = 27Sep2024.
To identify changes in a Code List across versions, click the drop-down in the Controlled Terminology Version field to view differences.
Note: The DMOD standard does not use Controlled Terminology.
Use Filter and Search Functionality
The filter and search functionality in the Standards module enables efficient retrieval of relevant information. Use the fields at the top of the window to filter by Controlled Terminology Version, Standards, Domains, and free text to narrow search results.
Use the Controlled Terminology Version drop-down to select a version date. (Helpful when comparing Code List values across Controlled Terminology Versions.)
Select the Standard to search using the Select Standards drop-down. By default, all standards are selected.
Use the Domains drop-down to choose a search category: Domains, Variables, Codelist, or CT Values. Domains is selected by default.
- Enter a keyword in the Search field (e.g., AE).
- Click the Magnifying Glass icon or press Enter to execute the search.
- View the results, which are grouped by standard and displayed in separate tabs at the top of the results list.
Click a tab for the desired standard, then select a link in the Domain Name column to view more details.
Example: Click the AE link in the Domain Name column under the SDTM tab to view domain-specific information.- Click the Reset button in the master header to clear all search criteria and return to the default view.