entimICE Define.xml Generator

Mission

In Entimo Integrated Clinical Environment (entimICE), a dedicated generator allows Define.xml for SDTM, ADaM and other datasets to be created from metadata domain definitions with just a few clicks.

Define.xml generator is based, like other Entimo’s tools, on a metadata driven architecture. Define.xml and Define.pdf files are created from metadata and can be used as communication tools in the data mapping process event before data is available. Terminology, value level metadata, and other data elements are included on the fly with consistent links. If any data elements have changed, you just need to press the button again for an up-to-date Define.

Benefits

1. Rapid creation without programming: Reusable metadata templates and comfortable GUI allow rapid creation without programming a single line of code.

2. Up-to-date information: Central repository maintains up-to-date information including templates accessible to all users.

3. Consistent definition: Controlled links between versioned elements provide for error-free define.

4. Universal approach for SDTM/ADaM define: Metadata driven concept allows to create define for SDTM, ADaM and custom structures.

What is new?

Entimo continuously develops and improves its products. The current release of the Define generator contains the following changes:

  • Define 2.0 with full support of ARM 1.0
  • Automatic linking of ADaM and SDTM datasets to analysis results tables

 Contact us for more information about Entimo's products, release information and roadmaps.

Define.xml Generator Highlights

Re-usable Templates for Data Elements

You can create and maintain data elements for standard and custom domains, value level metadata, controlled terminology and algorithm definitions using the built-in functionality of the metadata repository. All information is stored in the central repository and is subject to comprehensive traceability, version control and workflow. Due to the tool configurability, it supports customer-specific governance processes for metadata on global, project and study levels. Entimo provides you with a set of standard SDTM domains saving you precious time. The templates can be used for study level adjustments or for customer-specific models (SDTM+). For ADaM and SDTM, you can create domains from master data elements managed in the central repository.

Value level metadata

The repository allows maintaining value-level metadata which is required in the CDISC scope to generate a complete define.xml. Value-level metadata can be stored in the repository as tables and are simply linked to the corresponding domains. During Define generation, the tool searches in linked domains and tables that contain value level metadata. If attribute names match, a corresponding section with value level metadata and hyperlinks are automatically created in Define. You can use the mapping tool to create standard programs which would extract value level metadata from source data in a re-usable manner.

Transport Files

entimICE DARE contains a built-in tool to create transport files for datasets used in Define.xml. The user simply needs to select the required datasets and XPT files are automatically created in the selected destination folder. Prior to this, you can check the compliance of data to the metadata domain definitions which attribute level metadata by using a built-in structural check tool.

Controlled terminology

Controlled terminology can be managed in the repository as codelists or as codelist elements under governance and version control, as all other metadata types. To use controlled terminology in the Define scope, you need to create format catalogues and link them with domain definitions at the study level. In the domain definition, you simply need to specify the name of the format with controlled terms. All controlled terms from linked catalogues are automatically extracted and included in Define in a corresponding section with proper hyperlinks. The product contains an easy-to-use, graphic tool to create catalogues from formats. External dictionaries such as MedDRA and Who Drug are supported for Define - each attribute in domain definitions can be referenced to an external dictionary in metadata definitions.

 

Dependencies and Links

Links play a crucial role in the Define generation process. Configurable and generic, the entimICE DARE repository supports various study templates which can have a completely different folder structure where metadata, terminology, documents and other objects are stored. For this reason, Define elements need to be registered in the Define generator by including them in specific link types (e.g. link to blankcrf.pdf). Drag-and-drop GUI allows you to define necessary links between metadata and all required define elements and documents in a comfortable way.

Computational algorithms

Computational algorithms can be managed in the comments of domain definitions or as separate tables in the metadata repository. Thus you can create a library with study level or global algorithm definitions and use the library with all relevant domains by linking them to the library. The Define.xml generator searches linked domains and algorithm definitions and for matches found, it creates a separate section of used methods and hyperlinks in define.xml.

Scanning aCRF for Page References

A dedicated tool scans the linked annotated CRF, looking for occurrences of metadata attributes from domain definitions. The tool extracts page numbers for occurrences and stores them in metadata. Alternatively, users can manage page number references to the aCRF manually. The page numbers are used by the Define.xml generator to create hyperlinks from define.xml to the corresponding pages of the linked annotated CRF. The scanner supports regular expressions for attribute search. The patterns can be stored as templates and made available to other users.

Documentation and Style Sheets

The entimICE DARE repository allows not only metadata to be managed, but also all kinds of supplemental documentation required to create Define including style sheets for Define layout. The artifacts are simply registered in the Define generator and become part of the Define creation process.

Define.xml Generation

As the last step, you need only to select domains to be included – Define.xml and define.pdf are automatically created in a specified location. Controlled terminology and other data elements are included in define on the fly and are up-to-date with consistent links. If any data elements have changed, you just need to press the button again for an up-to-date Define.


  Download the fact sheet: submission tools

Domain level metadata

Domain level metadata

Attribute level metadata

Attribute level metadata

Value level metadata

Value level metadata

Library of algorithms

Central library with algorithm definitions

Transport files

GUI driven creation of transport files

CRF page scan

Scanning of aCRF for page references

Define 2.0

Define 2.0 XML and PDF