Standardized terminology for clinical trial protocols based on top-level ontological categories

Area of Science:

• Medical Informatics
• Clinical Trials
• Ontology Engineering

Background:

• Quality assurance in clinical trials is crucial for reliable data.
• Standardization of medical and trial-specific terminology is often lacking.
• Context-dependent definitions are needed for accurate concept representation.

Purpose of the Study:

• To present a new method for ontologically based standardization of concepts in clinical trial protocols.
• To improve the quality assurance of clinical trial protocols through standardized terminology.
• To develop a context-dependent data dictionary for medical and trial-specific terms.

Main Methods:

• Development of a data dictionary defining concepts and relations context-dependently.
• Utilization of domain-specific ontologies and the General Upper Ontology (GOL).
• Distribution of the data dictionary via the Onto-Builder software tool over the internet.

Main Results:

• A data dictionary for medical and trial-specific terms was created.
• Concepts and relations are defined context-dependently within the dictionary.
• The dictionary is accessible to medical research networks through the Onto-Builder tool.

Conclusions:

• The proposed method enables ontologically based standardization of concepts for clinical trial protocols.
• The context-dependent data dictionary facilitates improved quality assurance in clinical research.
• The Onto-Builder tool provides a mechanism for sharing standardized terminology across research networks.