Clinical research nursing is nursing practice with
a specialty focus on the care of research participants in
which nursing care delivery parallels the process of
clinical research study implementation (Figure 1). In
addition to providing and coordinating clinical care,
clinical research nurses have a central role in assuring
participant safety, maintenance of informed consent,
integrity of protocol implementation, accuracy of data
collection and recording, and appropriate follow-up.
Nursing care provided to research participants is
driven by study requirements and the collection of
research data as well as clinical indications. Patient
assessment and clinical data collection may include
clinical observations, clinical measurements, specimen
collection and preparation, and documentation
of research participantereported outcomes. Interventions
and study procedures may include administration
of investigational drugs, performance of an
experimental or investigational surgical or radiological
procedure, detailed clinical evaluation or phenotyping