Competencies and role of the Clinical Trial Nurse in Pediatric Hemato-Oncology: proposal for a National Core Curriculum and Job Description

Abstract

Background: clinical trials, particularly in oncology, require complex collaborative networks and multidisciplinary expertise to ensure scientific quality and participant safety. In this context, the Clinical Trial Nurse (CTN) plays a key role, especially in pediatric hemato-oncology, where clinical complexity and patient vulnerability demand highly specialized competencies. However, in Italy, there is still significant heterogeneity and a lack of shared standards regarding the CTN role, training and responsibilities.

Objectives: to define a clear and shared professional profile for the CTN in pediatric hemato-oncology by developing a national core curriculum and job description, aimed at standardizing education, competencies, evaluation and professional recognition.

Methods: an integrated approach was adopted, combining a review of the international literature with empirical data from a multicenter AIEOP survey. The process included three phases: identification of key competencies, analysis of the national context, and development of a shared competency model and job description, guided by the Competency-Based Education framework.

Results: a core curriculum structured into seven competency domains was developed: clinical, methodological, communication-relational, autonomy, critical thinking, leadership and teamwork. The job description outlines responsibilities, activities and observable standards, supported by performance indicators and outcomes to ensure quality of care, data integrity and patient safety.

Conclusions: formalizing the CTN role is essential to improve the quality, safety and consistency of pediatric clinical trials. The adoption of a shared national framework supports professional recognition, the development of advanced competencies and continuous improvement in research and care processes.