监查员在我院药物临床试验机构履职情况的调查分析

Investigation and Analysis of Performance of Clinical Research Associate in the Drug Clinical Trial Institutions of Our Hospital

目的:了解监查员在我院药物临床试验机构履职情况。方法:2017年8-11月,选择我院药物临床试验机构的机构人员、监查员及监查员领导共50名,通过扫问卷的二维码进行调查,问卷分为人口学资料及监查员履职情况两个部分。结果:监查员履职情况综合评分为3.70～4.48分,对应"一般～非常同意"的区间,其中处于"一般～同意"区间为V12、V16、V23、V25及V28共5项。结论:V12、V16、V23、V25及V28等5项是我院药物临床试验机构监查员履职的薄弱环节。机构应对监查员履职薄弱环节进行监管,并推广临床研究协调员及招募专员的模式;申办方或合同研究组织应提高组织能力及专业水平,并重视监查工作;另外可成立协会或联盟开展监查员行业培训和认证考试。

Objective:To investigate the performance of clinical research associate(CRA) in the drug clinical trial institutions of our hospital.Methods:From Aug.to Nov.2017,a total of 50 staff members,CRA and leaders of the CRA from the drug clinical trial institutions of our hospital were selected to conduct the survey by scanning the two-dimensional code of the questionnaire.There were two parts in the questionnaire,including demographic data and the performance of CRA.Results:The comprehensive score of the performance of CRA was from 3.70 to 4.48,corresponding to the interval of Neither Agree Nor Disagree-Strongly Agree,among which the interval of Neither Agree Nor Disagree-Agree was V12,V16,V23,V25 and V28,totally 5 items.Conclusion:V12,V16,V23,V25 and V28 were the five weak links in the performance of CRA in the drug clinical trial institutions of our hospital.The institution should supervise the weak links in the performance of CRA and promote the model of clinical research coordinator and recruitment specialist.The sponsor or the contract research organization shall improve the organizational capacity and professional level,and pay attention to the supervision work,in addition to the establishment of the association or the alliance to carry on the monitor profession training and the authentication examination.