JMIR Publications

ABSTRACT

Background:

Introduction: The competencies required for life sciences graduates to participate in human clinical research teams are now well defined.

Objective:

This study aims to establish a structured consensus on the core competencies students must acquire during their degree programs.

Methods:

A RAND-modified Delphi procedure was conducted using two rounds of online questionnaires, a virtual meeting, and a final review. The process began with questionnaire completed by experts from the UCO-IMIBIC promoting group (three principal investigators, one study coordinator, and one data manager). The 48 competencies initially proposed were reviewed by a group of 18 experts (six principal investigators, six study coordinators, and six data managers) representing six clinical research groups from universities and biomedical research institutes in Andalusia, Spain. The relevance of each proposed competency was rated on a 9-point Likert scale. A competency was accepted if it achieved a mean score of ≥7 points and at least 70% of the scores were within the top tertile (7–9 points).

Results:

The 18 experts achieved 100% consensus on a panel of 48 competencies organized into three sections: (i) fundamental concepts (23 competencies); (ii) clinical trial development (23 competencies); and (iii) certifications (2 competencies).

Conclusions:

This consensus defines the core competencies that life sciences graduates must acquire to work as human clinical trial investigators. It also provides a framework for designing training strategies in both undergraduate and graduate programs of study.