摘要
目的:探讨药物临床试验机构临床研究协调员(clinical research coordinator,CRC)的管理模式及难点。方法:2021年8—9月期间以广东省汕头市4家医院的225名相关工作人员为调查对象进行电子问卷调查。调查对象为药物临床试验质量管理规范办公室人员、临床科室医师、临床科室护士和辅助科室医护人员,其中107位来自综合医院,118位来自专科医院。调查内容包括对于CRC的基本认识、CRC在实际工作中的作用以及对当前CRC管理存在问题的建议和评价等。结果:109人(48.4%)不清楚CRC与研究对象所在单位的合作方式,96人(42.7%)不清楚CRC的具体职责。专科医院对CRC的熟悉程度高于综合医院(χ^(2)=42.89,P<0.001);药物临床试验质量管理规范办公室人员和临床科室医师偶尔接触和每天接触CRC的人数均高于临床科室护士和辅助科室医护人员(校正P值<0.008 3)。亟待解决的CRC管理问题集中于CRC缺乏固定工作场所及登录医院信息系统的权限设定问题。结论:研究对象对CRC的熟悉程度偏低,CRC的管理模式存在不足,应注重改善信息管理和福利体系,提高CRC的工作积极性。
Objective:To investigate the management model and difficulties of clinical research coordinator(CRC)in a drug clinical trial organization.Methods:An electronic questionnaire survey was conducted during August-September 2021 with 225 relevant staff from 4 hospitals in Shantou,Guangdong Province.The survey subjects were staff of the good clinical practice(GCP)office,physicians of clinical departments,nurses of clinical departments and medical staff of auxiliary departments,of which 107 were from general hospitals and 118 were from specialized hospitals.The survey included basic understanding of CRC,the role of CRC in practical work,and suggestions and evaluation of current problems in CRC management.Results:109(48.4%)were unclear about how the CRC worked with the study subjectsorganization,and 96(42.7%)were unclear about the specific responsibilities of the CRC.The familiarity with CRC was higher in specialized hospitals than in general hospitals(χ^(2)=42.89,P<0.001);the number of personnel in the GCP office and physicians in clinical departments who had occasional and daily exposure to CRC was higher than that of nurses in clinical departments and medical staff in ancillary departments(adjusted P value<0.0083).Urgent CRC management issues focused on the lack of a fixed workplace for CRCs and the setting of permissions for logging into hospital information systems.Conclusion:The familiarity of survey subjects with CRC is low,the management model of CRC is deficient,and the focus should be on improving the information management and welfare system to promote the motivation of CRC.
作者
张勤
朱素娟
郭岱年
陈蕾
ZHANG Qin;ZHU Sujuan;GUO Dainian;CHEN Lei(Cancer Hospital of Shantou University Medical College,Shantou 515041,China)
出处
《汕头大学医学院学报》
2023年第2期115-119,共5页
Journal of Shantou University Medical College
基金
广东省医学科学技术研究基金(A2020528)。
关键词
药物临床试验
临床研究协调员
问卷调查
管理模式
drug clinical trial
clinical research coordinator
questionnaire survey
management mode
