Consensus on Core Competencies of Undergraduate Life Sciences Students for Entry-Level Participation in Clinical Trials: RAND-Modified Delphi Study

The competencies required of life sciences graduates to participate in clinical trial research teams are poorly defined.

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

A RAND-modified Delphi procedure was conducted using 2 rounds of online questionnaires, a virtual meeting, and a final review. The process began with a questionnaire completed by experts from the University of Córdoba and the Maimonides Institute for Biomedical Research of Córdoba (3 principal investigators, 1 study coordinator, and 1 data manager). The 48 competencies initially proposed were reviewed by a panel of 18 experts representing 6 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. Competencies were accepted if they achieved a mean score of 7 points or higher and at least 70% of ratings in the top tertile (scores of 7-9).

The 18 experts achieved 100% consensus on a panel of 48 competencies organized into 3 sections: fundamental concepts (n=23, 47.9% of the competencies), clinical trial development (n=23, 47.9% of the competencies), and certifications (n=2, 4.2% of the competencies).

This consensus defines the core competencies required of undergraduate life sciences students for entry-level participation in clinical trial research. It also provides a framework for designing training strategies in both undergraduate and graduate programs of study.