Research Nurse Roles and Functions in Clinical Trials for Assisted Reproductive Drugs

Summary

Clinical research nurses are closely involved in assisted reproductive drug trials. This review discusses how their role can be better defined and supported through clearer position management, specialty training, quality-control awareness, and career-development pathways in reproductive medicine.

Abstract

Assisted reproductive drug clinical trials require close coordination between reproductive medicine, nursing, embryology, pharmacy, laboratory, data management, and regulatory teams. Their implementation is complicated by cycle-dependent treatment schedules, frequent endocrine and ultrasound monitoring, strict medication timing, reproductive specimen handling, pregnancy follow-up, and safety reporting. These features create specific demands for clinical research nurses (CRNs), whose responsibilities extend beyond routine nursing care. This review summarizes the roles and functions of CRNs in assisted reproductive drug clinical trials in China, focusing on position management, subject management, investigational product management, material and specimen traceability, data documentation, quality control, and inspection readiness. Existing literature suggests that CRNs can support protocol implementation, subject protection, visit coordination, adverse-event reporting, and data integrity when their responsibilities are clearly defined. However, CRN practice in this field remains insufficiently standardized, particularly regarding admission criteria, specialty training, competency evaluation, workload allocation, and career development. Thus, establishing reproductive-medicine-specific CRN training systems and position-management frameworks may improve trial quality and support the professional development of clinical research nursing in assisted reproductive medicine.

Introduction

In China, declining fertility rates and adjustments to national fertility policies have increased attention to infertility diagnosis and treatment¹. Infertility is commonly defined as the failure to achieve pregnancy after 12 months of regular unprotected intercourse and affects many reproductive-age couples worldwide². Accordingly, assisted reproductive treatment has become an important component of reproductive medicine, particularly for couples with ovulatory dysfunction, tubal disease, diminished ovarian reserve, male-factor infertility, or unexplained infertility.