ClinOps-O
Clinical Operations Ontology
Clinical operations encompass logistical, administrative, and compliance-related activities and processes that support the planning, execution, and management of clinical trials from inception to completion.
Clinical operations are either directly or indirectly connected to the clinical investigations that a specific patient population undergoes to evaluate the efficacy and safety of a specific drug.
Clinical trial sponsors have a precise role and obligations as defined by regulation:
Problem statements
-
- Clinical trial operations tasks are defined and performed differently from one trial sponsor to an other
- Clinical trial operations related to clinical investigations are requested for specific trial purposes (drug, population, efficacy, safety, exploratory endpoints) that can differ from routine clinical investigations
- Clinical investigations rely on clinical experience and preferences at different levels (country, CRO, hospital, expert)
Objective
Standardized (for humans and machines) the concepts and their relationships characterizing clinical operations.
Having machine-readable and -actionable standards is a prerequisite for:
-
- automation
- insight generation
Who would benefit from it?
- Patients: optimized and minimal trial-specific clinical investigations (reduced travels and time spent at clinical site and data collection)
- Clinical professional: freeing-up resources, performing less duplicate assessments
- Trial sponsors: shortening time and reducing cost to setup and conduct clinical trial; optimizing data collection