临床研究护士与临床研究协调员的工作内容调查
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摘要
目的:调查临床试验中临床研究护士(CRN)与临床研究协调员(CRC)的工作内容的异同点。方法:采用横断面调查,便利抽样调查了60名专职临床研究护士。55名临床研究护士完成了《临床研究护士和研究协调员角色及工作内容调查问卷》的调查。结果:在被调查的59项工作内容中,医院专职临床研究护士与来自临床试验现场管理组织(SMO)的临床研究协调员相比,49项工作内容有明显差异。其中,"为受试者提供护理照顾"、"对临床护士进行新药相关知识的宣教,提供指导"、"给予受试者及其家属健康指导"、"回收受试者剩余试验用药品、包装及服药日记卡,计数并记录"、"试验用药品的配制和注射"、"血液标本的采集"、"尿标本的采集"、"必备急救设备管理"、"发现并处理临床试验对于受试者产生的伦理和个人经济方面的利益冲突"、"参与院内继续教育,将新的知识及经验传播给临床护士"10项工作内容差异最大。结论:临床研究护士和临床研究协调员是临床试验中的2个不同角色,因执业范围和管理机构不同,两者的工作侧重不同,不能用临床研究协调员完全替代临床研究护士完成临床试验的协调和管理工作,应合理分工、各司其职以保证临床试验的顺利实施和质量。
Objective: To investigate the similarities and differences between the work contents of clinical research nurses( CRN) and clinical research coordinators( CRC) in clinical trials. Methods: A cross-sectional survey was conducted to facilitate the sample survey of 60 full-time CRNs. Totally 55 clinical research nurses completed the survey of the "Clinical research nurses and research coordinators role and work content questionnaire". Results: Of the 59 work items surveyed,there were significant differences in the contents of the 49 jobs between full-time CRNs and the CRCs from site management organizations( SMO). Among them,ten items have the most obvious difference. "Provide nursing care for subjects","Provide guidance and knowledge about new drug to clinical nurses","Giving guidance to subjects and their families","Count and record the remaining clinical trial drugs and packaging,check medication journal cards","Preparation and injection of clinical trial drugs","Collection of blood specimens","Collection of urine specimens","Emergency equipment management","Manage potential ethical and financial conflicts of interest for subjects","Participate in continuing education in the hospital,and disseminate new knowledge and experience to clinical nurses". Conclusion: CRNs and CRCs aretwo different roles in clinical trials. Due to different scope of practice and belonging to different management institutions,work focus of them are different. CRCs cannot completely replace CRNs. CRNs and CRCs should be reasonably divided into different roles to ensure implementation of clinical trials and improve the quality.
Objective: To investigate the similarities and differences between the work contents of clinical research nurses( CRN) and clinical research coordinators( CRC) in clinical trials. Methods: A cross-sectional survey was conducted to facilitate the sample survey of 60 full-time CRNs. Totally 55 clinical research nurses completed the survey of the "Clinical research nurses and research coordinators role and work content questionnaire". Results: Of the 59 work items surveyed,there were significant differences in the contents of the 49 jobs between full-time CRNs and the CRCs from site management organizations( SMO). Among them,ten items have the most obvious difference. "Provide nursing care for subjects","Provide guidance and knowledge about new drug to clinical nurses","Giving guidance to subjects and their families","Count and record the remaining clinical trial drugs and packaging,check medication journal cards","Preparation and injection of clinical trial drugs","Collection of blood specimens","Collection of urine specimens","Emergency equipment management","Manage potential ethical and financial conflicts of interest for subjects","Participate in continuing education in the hospital,and disseminate new knowledge and experience to clinical nurses". Conclusion: CRNs and CRCs aretwo different roles in clinical trials. Due to different scope of practice and belonging to different management institutions,work focus of them are different. CRCs cannot completely replace CRNs. CRNs and CRCs should be reasonably divided into different roles to ensure implementation of clinical trials and improve the quality.
引文
[1] HASTINGS CE,FISHER CA,MCCABE MA,et al. Clinical research nursing:a critical resource in the national research enterprise[J]. Nurs Outlook,2012,60(3):149-156.
[2] BEVANS M,HASTINGS C,WEHRLEN L,et al. Defining clinical research nursing practice:results of a role delineation study[J]. Clin Transl Sci,2011,4(6):421-427.
[3] Responsibilities of PIs and CRCs. Office of Ethics and compliance,University of California,San Francisco[EB/OL].(2016-02-29). http://irb. ucsf. edu/responsibilities-pis-and-crcs.
[4] DAUGHERTY P,LEOS D,SCHMIEDER L,et al. Oncology Clinical Trials Nurse Competen-cies[J]. Oncology Nursing Society,2010:1-16.
[5] KANG HS,SON HM,LIM NY,et al. Job analysis of clinical research coordinators using the DACUM process[J]. J Korean Acad Nurs,2012,42(7):1027-1038.
[6] JONES CT,WILSON LL. Clinical research nurse perspectives on unsupervised,non-nurse clinical research coordinators[J]. The Monitor,2014,28(1):12-19.
[7] JONES CT,HASTINGS C,WILSON LL. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators[J]. Nurs Outlook,2015,63(4):474-483.
[8]卜擎燕,熊宁宁,邹建东,等.临床试验的重要角色:临床研究协调员[J].中国临床药理学与治疗学,2006,11(10):1190-1193.
[9]刘晓红,白玲玲,柏冬丽,等.国内外研究护士发展现状及引发的思考[J].中国护理管理,2008,8(12):40-42.
[10]彭朋,元唯安,胡薏慧,等.临床研究协调员的管理模式及其利弊[J].医药导报,2015,34(10):1399-1401.
[11] OCKER B,PLANK DM. The research nurse role in a clinic-based oncology research setting[J]. Cancer Nurs,2000,23(4):286-289.
[12] EHRENBERGER HE,LILLINGTON L. Development of a measure to delineate the clinical trials nursing role[J]. Oncol Nurs Forum,2004,31(3):64-68.
[13] OLSON RE,BOISJOLIE C,GOLDMAN JA,et al. Scope of practice in clinical research:a cardiovascular research institute's approach[J]. The Monitor,2012,26(6):23-30.
[14] CASTRO K,BEVANS M,MILLER-DAVIS C,et al. Validating the clinical research nursing domain of practice[J]. Oncol Nurs Forum,2011,38(2):72-80.
[2] BEVANS M,HASTINGS C,WEHRLEN L,et al. Defining clinical research nursing practice:results of a role delineation study[J]. Clin Transl Sci,2011,4(6):421-427.
[3] Responsibilities of PIs and CRCs. Office of Ethics and compliance,University of California,San Francisco[EB/OL].(2016-02-29). http://irb. ucsf. edu/responsibilities-pis-and-crcs.
[4] DAUGHERTY P,LEOS D,SCHMIEDER L,et al. Oncology Clinical Trials Nurse Competen-cies[J]. Oncology Nursing Society,2010:1-16.
[5] KANG HS,SON HM,LIM NY,et al. Job analysis of clinical research coordinators using the DACUM process[J]. J Korean Acad Nurs,2012,42(7):1027-1038.
[6] JONES CT,WILSON LL. Clinical research nurse perspectives on unsupervised,non-nurse clinical research coordinators[J]. The Monitor,2014,28(1):12-19.
[7] JONES CT,HASTINGS C,WILSON LL. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators[J]. Nurs Outlook,2015,63(4):474-483.
[8]卜擎燕,熊宁宁,邹建东,等.临床试验的重要角色:临床研究协调员[J].中国临床药理学与治疗学,2006,11(10):1190-1193.
[9]刘晓红,白玲玲,柏冬丽,等.国内外研究护士发展现状及引发的思考[J].中国护理管理,2008,8(12):40-42.
[10]彭朋,元唯安,胡薏慧,等.临床研究协调员的管理模式及其利弊[J].医药导报,2015,34(10):1399-1401.
[11] OCKER B,PLANK DM. The research nurse role in a clinic-based oncology research setting[J]. Cancer Nurs,2000,23(4):286-289.
[12] EHRENBERGER HE,LILLINGTON L. Development of a measure to delineate the clinical trials nursing role[J]. Oncol Nurs Forum,2004,31(3):64-68.
[13] OLSON RE,BOISJOLIE C,GOLDMAN JA,et al. Scope of practice in clinical research:a cardiovascular research institute's approach[J]. The Monitor,2012,26(6):23-30.
[14] CASTRO K,BEVANS M,MILLER-DAVIS C,et al. Validating the clinical research nursing domain of practice[J]. Oncol Nurs Forum,2011,38(2):72-80.