Standards Development

Scope

Standardization in the field of clinical trial business and operations, including, but not limited to, semantic machine-readable ontologies, data interoperability, workflow integration, efficient decisionmaking, clinical trials management, site feasibility assessments, patient recruitment strategies, ontology development automation, and streamlined operations.

Purpose

The purpose of the programme of work shall correspond to and clearly reflect the aims of the standardization activities, focusing on the development and adoption of the ClinOps Ontology for clinical trial operations.

Each item on the programme of work is defined by its subject, such as site feasibility, patient recruitment, and trial budget management, and the aspect to be standardized, including data elements, process steps, and automation methods.

This standardization aims to streamline operations, enhance data interoperability, and improve the overall efficiency and quality of clinical trials. Supplementary justification:

This programme includes the successful proof of concept in Phase 1, which demonstrated the feasibility of ontology-based standardization in site feasibility and cross-pharma collaboration.

Phase 2 will prioritize expanding the ontology's scope to additional clinical trial processes, ensuring comprehensive standardization across various operational aspects.

Priorities include developing a version 1.0 ontology for release, establishing relationships with standards agencies for official recognition, and engaging software vendors for widespread adoption, with target dates aligned to these objectives. (Please use this field or attach an annex)