Clinical Research Nurses: Roles and Qualifications in South Korea
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Clinical Research Nurses: Roles and Qualifications in South Korea
Ihnsook Jeong Assistant Professor, College of Nursing, Pusan National University Hyun-Sook Kang Professor, College of Nursing, Kyung Hee University Won-Ock Kim Professor, College of Nursing, Kyung Hee University
Key Words Clinical research nurse; Role; Qualification This study was supported by the Pusan National University Grant. Correspondence Address Ihnsook Jeong, College of Nursing, Pusan National University, 1ga Ami-dong, Seo-Gu, Busan, 602-739 South Korea (e-mail: [email protected]).
This study aimed to determine the standard roles, proficiency, and qualification of clinical research nurses (CRNs) in clinical trials/research in South Korea. Seventy-one investigators with experience working with CRNs and 79 current CRNs were conveniently sampled. Data were collected using a questionnaire including demographics, perceived roles, proficiency, and qualification of CRNs. The top three roles of CRNs perceived by investigators were scheduling subjects, communicating with investigator and sponsor, and completing case
INTRODUCTION Since 1990, the Korean government has heavily invested in the development of new drugs in order to be independent of foreign drug development (1). This investment has increased expectations for the increase of domestic clinical trials (2). The number of clinical trials has necessitated the development of a proper infrastructure to improve the quality of the nation’s clinical trials to those of advanced countries. Thus, to secure the credibility of clinical trials and to protect participating subjects, the Korea Good Clinical Practice (KGCP) was established in 1995 and was revised in 2000 following International Conference on Harmonisation GCP. While legal and systematic infrastructure have been established to a certain extent, a proper infrastructure for human resources, which is the most important aspect of clinical trials, has not yet been established. This situation has led to a shortage of qualified professionals in clinical trials (3). Clinical research nurses (CRNs) are professional nurses who have a substantial amount of responsibility for clinical trials and are required to conduct the clinical trials according to the principle investigator’s instructions (4,5). Phar-
report forms. The top three roles of CRNs perceived by current CRNs were completing case report forms, communicating with investigator and sponsor, and screening subjects . The most important proficiencies perceived by investigator and current CRNs was communication and human relationship skills. Both investigators and current CRNs considered the key role of CRNs as communicating with investigator and sponsor; a bachelor’s degree and more than one year of clinical experience were seen as the minimum qualification.
macists and laboratory technicians can also assist the principal investigators in conducting clinical trials; they are collectively known as clinical research coordinators (CRCs) (4,6). CRCs are generally preferred to have knowledge
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