Glossary

This glossary of terms, acronyms, and abbreviations provides definitions used throughout the project.

Data Definition Engine (DDE)

A software tool used to populate the Data Definition Specification (DDS) model as JSON to facilitate the generation of study artifacts.

Data Definition Specification (DDS)

The model at the center of the DDE solution which carries the complete set of metadata needed to generate these artifacts in addition to supporting other automation tasks.

Define-XML

An Extensible Markup Language format that stores and transmits metadata of tabular dataset structures.

LinkML

An open-source schema language for modeling data in YAML, supported by a toolchain for validation, conversion, and code/schema generation.

ODM CRFs

Operational Data Model format that stores clinical data in Case Report Forms.

Dataset-JSON shells

Data structure templates that can store clinical data in Dataset-JSON format.

Trial Design datasets

Datasets that lay out the design and timeline of a clinical trial.