The entimICE DARE repository is truly model-agnostic. It can handle metadata for standard CDISC data modes such as CDASH, SDTM, ADaM, and SEND as well as legacy and customer-specific data models. EDC-specific CRF and non-CRF data models for lab, ECG, PK and other data can be easily accommodated in the MDR. Every configured model has an extendible set of attributes and separately configurable workflows. This ability to support such varying metadata types is provided by an integrated management console called the entimICE Structure Administrator. This module allows the existing software configuration of the repository to be adjusted without changing the application code.
Flexible organization of standard metadata
All standards can be managed at global, therapeutic, project and study levels - there is no limitation to the hierarchy depth and complexity. Folder structures can be created based on preconfigured templates. Hierarchies are automatically populated during the setup process. Multiple versions of productive standards can be managed in parallel.
CDISC SHARE support
CDISC SHARE is the industry source of standard CDISC metadata and provides metadata files for download in different formats (e.g. CSV, ODM/define.xml). The entimICE DARE MDR supports a standard process to load CDISC SHARE files into the repository based on the available tools (e.g. ODM import). The CDISC SHARE metadata can be stored in specially configured repository areas for reference purposes and post-processing. entimICE DARE has a built-in web server component. When the CDISC SHARE repository supports open web services, the MDR can be directly connected to the CDISC SHARE repository to download standards in an automated way.
Impact analysis and semantic search
The impact analysis tool allows consequences of changes to be investigated across data models and standards levels. The comparisons can be performed for complete data models or single data elements. An interactive report of all deviations is created. This facilitates the detection of potential issues very early in the change process. By using the semantic search engine, users can define, store and run simple and complex retrieval queries. They can search metadata content, lifecycle states and historical values within the repository. Users can even integrate queries and their search results into automation processes. A highlight of the search engine is its ability to search through links and dependencies - the entimICE DARE search provides a shortcut to required results.
The system supports the configuration of lifecycles for all repository elements across development, validation and production areas. The lifecycles include the conditions for locking of single objects or complete models driven by their status. Validation criteria can be defined for every standard type managed in the system. Changes to lifecycle states can automatically trigger other actions or notifications.
Graphic linking of standards
A key element for efficient re-use of standards is the linking technology implemented in the system. Standards such as data elements, domains, codelists and formats, macros, standard programs and mappings can, but do not need to be copied across the hierarchies. They can be easily addressed by using search paths and they are automatically applied in required areas. An exceptional feature of the solution is its ability to automatically track and report the dependencies between elements in the process. This eliminates the daunting efforts required to manually insure that all dependent objects are consistent and up-to-date.
Metadata validation engine
The consistency and integrity of metadata is steered by metadata definition rules. Rules can include complex checks of multiple data elements or complete domains. The checker can be part of the customer-specific workflow. Additional checks can be defined and included in the governance process.
From protocol to reporting metadata
The highlight of the solution is its ability to store not only structured data models such as CDASH or SDTM, but to underpin the end-to-end process, starting from protocol to reporting metadata, including value level and domain metadata, codelists, terminology and parameters, and much more.
Study CRF builds
The entimICE DARE MDR supports data management activities with powerful tools. Mock CRF layouts with annotations and Excel specifications can be stored in the integrated file system under version control. In the MDR, global librarians can manage the super-set of forms, attributes, dictionaries, data dictionary entries, and visits, including related checks, derivations and custom functions. The standard CRF metadata help clinical programmers design robust study builds in a short time. Prepared CRF builds can validated with the metadata checker that supports customer-specific rules. The CRF preview toolbox allows the metadata to be displayed as CRFs and can incorporate EDC-specific layout validation rules.
The build metadata can be exported in various formats including ODM/XML, CSV, XLS and Rave’s ALS (Architect Loader Specification).
Entimo's mapping module offers a metadata-driven user interface to define standard mapping algorithms from source to target data structures. It can load metadata definitions from the MDR and generates executable mapping programs (SAS) as well as complete mapping specifications. The mapping tool provides a large pool of built-in conversion algorithms for standard data transformations. Moreover, users can create user-defined standard algorithms encompassing repeating transformations, thus reducing redundant work. Even complex transformation algorithms and complete mapping definitions can be stored as templates. This allows the creation of a company-wide standard mapping library containing all possible data sources and algorithms. Built-in consistency checks help detect logical and structural problems.
Easy exchange with external applications
entimICE DARE serves as the metadata delivery environment and supports numerous clinical processes with standard metadata elements. Object content, properties and links can be easily imported or exported in a vast range of file formats via standard interfaces. The solution can take advantage of web services for access to third party applications, or can wrap actions as a web service for activation from external systems. Information can be exchanged in the online, batch or scheduled modes. Mapping of metadata and lifecycles with external third party tools provides overall process consistency and traceability throughout the lifecycle.
Robust change management process
entimICE DARE supports robust governance for all standard types. The process can begin with electronic change requests for the creation or update of repository elements. The solution includes a graphical form designer which allows authorized users to rapidly create new electronic forms for different change request types. Change requests can be enriched with workflows and automatic notification to dedicated roles. Change outcomes can be attached or linked to the electronic forms, allowing reviewers easy navigation even in hierarchies with complex standards.
Audit trail and version control
entimICE DARE is a validated solution which fulfills GxP and 21 CFR Part 11 requirements including regulatory compliant audit trail with electronic signatures. It makes available all necessary tools to support and report on all critical user and system activities, if required. The environment not only handles audit trails, but also provides full-fledged version control. Versioning can be made available for all standards types including specifications, edit checks, programs, attribute items, domain definitions and data. If versioning is not necessary under certain circumstances, it can be completely deactivated.
Download the fact sheet: entimICE DARE MDR