Purpose: The purpose of this study was to explore the role performance and related factors of clinical research nurses (CRN) in the process of clinical trials of new drug development. Methods: Study participants were CRN whose affiliation was in non-capital areas and who had been working longer than three months at the time of the data collection. The data collection was conducted with a semi-structured questionnaire development by Hwang & Go, 2011 comprising 16 items of participants’ characteristics and 60 items of role performance via in-person and online. Additionally, opinions which would be necessary to establish the CRN role were questioned for the future. A total of 141 questionnaires of 151 questionnaires responses were analyzed using descriptive statistics, t-test, and ANOVA for data analysis as appropriate. Results: The level of overall role performance was above average (5.61± 0.90) with the highest in subject care (6.04± 0.96) and management and the lowest in self-development (4.39± 1.52). The only factor affecting overall role performance was employment status and the only sub-category affected by factors of employment status, and some general characteristics was self-development. Conclusion From study results, it can be concluded that the CRN seem to perform their proper role. Nonetheless, self-development should be considered as critical aspect for better CRN competency, which is an important aspect toward improving the CRN role performance. Additionally, efforts to improve the level of role performance must be established through stable employment and concrete departmental placement as suggested in this study.

Background: The direct method for reference interval (RI) estimating is limited due to the requirement of resources, difficulties in defining a non-diseased population, or ethical problems in obtaining samples. We estimated the RI for inflammatory biomarkers using an indirect method (RII). Methods: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and presepsin (PSEP) data of patients visiting a single hospital were retrieved from April 2009 to April 2021. Right-skewed data were transformed using the Box-Cox transformation method. A mixed population of non-diseased and diseased distributions was assumed, followed by latent profile analysis for the two classes. The intersection point of the distribution curve was estimated as the RI. The influence of measurement size was evaluated as the ratio of abnormal values and adjustment (n×bandwidth) of the distribution curve. Results: The RIs estimated by the proposed RII method (existing method) were as follows: CRP, 0–4.1 (0–4.7) mg/L; ESR, 0–10.2 (0–15) mm/hr and PSEP, 0–411 (0–300) pg/mL. Measurement sizes ≥2,500 showed stable results. An abnormal-to-normal value ratio of 0.5 showed the most accurate result for CRP. Adjustment values ≤5 or >5 were applicable for a measurement size <25,000 or ≥25,000, respectively. Conclusions The proposed RII method could provide additional information for RI verification or estimation with some limitations.