Define.xml Generator

Three reasons to use Entimo’s Define.xml Generator:

1. Rapid creation
Reusable metadata templates allow rapid creation in less than an hour

2. Up-to-date information
Central repository maintains up-to-date information

3. Consistent definition
Comfortable GUI provides for consistent definition

The CDISC Case Report Tabulation Data Definition Standard (CRT-DDS) known as Define.xml requires several interdependent information elements to be bundled together in a submission package: Datasets descriptions (such as type, origin, role, comment, core as attribute level metadata in CDISC terms) are combined with domain level metadata (structure, purpose, class). Value level metadata must be linked to attribute metadata. Controlled terminology is included as code lists or references to dictionaries. Links to corresponding transport files and annotated CRF have to be consistently defined. In addition, algorithms might be part of Define.xml. Manual programming is tedious, time-consuming and hard to maintain if changes are required.

In Entimo’s Integrated Clinical Environment (entimICE), a dedicated generator allows to create Define.xml with several mouse clicks from metadata domain definitions. Only four steps are required:

1. Use Metadata Templates
Entimo provides you with a set of standard SDTM domains saving your precious time. The templates can be used as they are or adjusted to customer specific models (SDTM+). Domain level metadata is already preconfigured for standard SDTM domain definitions.

2. Define Data Elements
You can comfortably create and maintain additional data elements such as value level metadata and algorithms using powerful data grid with filtering and query definition dialog. All information is stored in the central repository and is subject to full-fledge traceability, version control and workflow. If available, you can load datasets with the required information by using dedicated file and database wizards.

3. Define Dependencies and Links
Drag-and-drop GUI allows you to define necessary links between the metadata and all required data elements. A highlight of the tool is the aCRF page extractor which automatically scans aCRF for page numbers where domain attributes are referenced and stores them in domain metadata.

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

Easy as this - no programming, few mouse clicks away!
 

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The Define.xml Generator is part of entimICE^® - Entimo's fully GCP and 21 CFR Part 11 compliant, modular and controlled e-clinical solution platform.

Further Info

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