Patient-Centered Activities Performed by Clinical Research Nurses in Clinical Trials: A Scoping Review of Enacted Practice.

Background/Objective: Clinical Research Nurses (CRNs) are recognized members of multidisciplinary teams in clinical trials (CTs), contributing to both research procedures and patient-centered care. Although competency frameworks describe the expected domains of CRN practice, less is known about how these competencies are enacted in patient-centered activities during CTs. This scoping review aimed to examine how patient-centered activities are enacted by Clinical Research Nurses in clinical trials. Methods: A scoping review was conducted following the Joanna Briggs Institute methodology and guided by the PRISMA-ScR checklist. A literature search was performed in MEDLINE, CINAHL, and EMBASE, complemented by gray literature searches across Google Scholar, GreyLit, and clinical research nursing association websites. Studies published in English over the last 20 years were included if they described patient-centered activities enacted by CRNs within CTs. Results: Twenty-one studies were included, reporting data from more than 1800 participants, primarily from survey-based research conducted across North and South America, Europe, Asia, Australia and New Zealand. CRNs were frequently described as involved in direct patient care, safety monitoring, patient education, follow-up coordination, and investigational product management. Variability across studies was reported in the implementation and level of autonomy associated with these activities. Studies from the UK, USA, Australia, Canada, Sweden, and New Zealand described CRNs as independently involved in activities such as informed consent and recruitment, whereas studies from Italy and South Korea more frequently reported physician-supported or supervised involvement in these tasks. Conclusions: This scoping review mapped how patient-centered activities performed by CRNs are described across clinical trial contexts. The findings highlight the broad range of relational, clinical, educational, and coordinative activities attributed to CRNs in supporting research participants throughout clinical trials, while also identifying variation in how these activities are enacted across studies and settings. The review contributes to the current understanding of the patient-centered dimension of CRN practice and supports further research exploring how these activities are implemented across different clinical trial contexts.