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Clinical Trial Nurse's Role in Safety Reporting

Authors

  • Christina Catania RN, BSN

    Corresponding author
    1. Christina Catania, RN, BSN, is a Drug Safety Associate, Drexel University, Philadelphia, Pennsylvania, USA.
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Christina Catania, RN, BSN, Drexel University, 3141 Chestnut Street, Philadelphia, PA, 19104, USA. E-mail: cmc326@drexel.edu

Abstract

The clinical trial nurse (CTN) can have a substantial amount of responsibility for clinical trials and can perform many roles in the management of clinical trials. Although new opportunities for the registered nurse in clinical trials have emerged in recent years, there remains to be a dearth of literature surrounding the important roles of the CTN in clinical trials. The CTN is a specialty-nursing role that is unfamiliar to many, including some nurses. Therefore, it is important to address this gap in the literature and enlighten the nursing profession and others about the roles of the nurse in clinical trials. This article aims to explore and provide an overview of the CTN's role in safety reporting. Safety reporting is a significant component of clinical trials by protecting the rights, safety, and welfare of subjects. The CTN integrates and utilizes his or her knowledge, experience, skills, and sound ethical principles when performing the duties of this role. This allows the CTN to be a vital member in the safety-reporting process and in the protection of subjects.

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