CAJ | 학술논문

目的：构建药物临床试验研究护士工作内容指标体系，以明确研究护士职责。方法以药物临床试验质量管理规范（good clinical practice，GCP）为依据，通过文献回顾、专家访谈，采用德尔菲法，通过2轮21名专家咨询确立药物临床试验研究护士工作内容指标体系。结果经过2轮专家咨询，确立了药物临床试验研究护士工作内容指标体系包括一级指标9项、二级指标47项。2轮专家咨询的积极系数分别是100%、90%，2轮专家咨询的协调系数检验均具有统计意义（P＜0.01）；第2轮专家咨询判断系数为0.91，熟悉系数为0.75，权威系数为0.83。结论经专家咨询及修改、删除条目，构建药物临床试验研究护士工作内容指标体系，结果可靠、信度较高，确立了药物临床试验研究护士工作内容为研究护士的培养、发展提供依据。
목적：구건약물림상시험연구호사공작내용지표체계，이명학연구호사직책。방법이약물림상시험질량관리규범（good clinical practice，GCP）위의거，통과문헌회고、전가방담，채용덕이비법，통과2륜21명전가자순학립약물림상시험연구호사공작내용지표체계。결과경과2륜전가자순，학립료약물림상시험연구호사공작내용지표체계포괄일급지표9항、이급지표47항。2륜전가자순적적겁계수분별시100%、90%，2륜전가자순적협조계수검험균구유통계의의（P＜0.01）；제2륜전가자순판단계수위0.91，숙실계수위0.75，권위계수위0.83。결론경전가자순급수개、산제조목，구건약물림상시험연구호사공작내용지표체계，결과가고、신도교고，학립료약물림상시험연구호사공작내용위연구호사적배양、발전제공의거。
Objective To establish job content index system for research nurse and to define research nurse ’ responsibility. Methods Based on good clinical practice (GCP), literature review, interview and Delphi method were used to establish the job content indexes system through a two-round expert consultation among 21 experts. Results After two rounds of expert consultations, 9 first-level indicators and 47 second-level indicators of job content were identified. The experts ’ positive coefficients in two rounds of consultations were 100% and 90% respectively, and both of the coordination coefficients were statistically significant (P<0.01). In the second round of consultation, the experts ’ coefficient of determination was 0.91, familiar coefficient 0.75, and authority coefficient 0.83. Conclusion With high reliability and credibility, job content index system for research nurse provides the basis for the training and development of research nurses.