CAJ | 학술논문

目的探讨临床医师对临床监察员(CRA)的满意度及其影响因素,对CRA的教育提出合理化建议.方法从5所三级甲等医院参加过临床试验的临床医师中随机抽取160名进行问卷调查,调查问卷采用李克特量表(Likert scale)5点测量法,内容包括4个层面12个维度,即工作态度、专业知识和能力、沟通协调能力、项目管理能力.利用SPSS 15.0软件进行数据处理和统计分析.用列联表的x2分析调查对象的属性特征与其对CRA总体满意度的关联性.结果 12项指标均值在2.28～3.75,总体满意度不高.其中,对CRA的服务意识、试验方案熟悉程度和CRF填写方面的满意度最高,分别为74.04％、61.70％,其余10项指标的满意度均＜50.00％.卡方分析结果显示,性别、学历、职称与总体满意度没有关联；参加过和未参加过培训的人员的总体满意度存在差异(P＜0.05),参与试验数量不同的人员之间总体满意度也存在显著差异(P＜0.01).结论临床医师对CRA的总体满意度不高,通过加强CRA的培训、建立CRA职业资格准人制度和加强临床医生对临床试验的重视和临床试验的能力以规范临床试验行业发展,提高我国的临床试验水平.
목적 탐토림상의사대림상감찰원(CRA)적만의도급기영향인소,대CRA적교육제출합이화건의.방법 종5소삼급갑등의원삼가과림상시험적림상의사중수궤추취160명진행문권조사,조사문권채용리극특량표(Likert scale)5점측량법,내용포괄4개층면12개유도,즉공작태도、전업지식화능력、구통협조능력、항목관리능력.이용SPSS 15.0연건진행수거처리화통계분석.용렬련표적x2분석조사대상적속성특정여기대CRA총체만의도적관련성.결과 12항지표균치재2.28～3.75,총체만의도불고.기중,대CRA적복무의식、시험방안숙실정도화CRF전사방면적만의도최고,분별위74.04％、61.70％,기여10항지표적만의도균＜50.00％.잡방분석결과현시,성별、학력、직칭여총체만의도몰유관련；삼가과화미삼가과배훈적인원적총체만의도존재차이(P＜0.05),삼여시험수량불동적인원지간총체만의도야존재현저차이(P＜0.01).결론 림상의사대CRA적총체만의도불고,통과가강CRA적배훈、건립CRA직업자격준인제도화가강림상의생대림상시험적중시화림상시험적능력이규범림상시험행업발전,제고아국적림상시험수평.
Objective To investigate the satisfaction of clinicians on clinical research associates (CRA)and its influencing factors,for the purpose of providing rationalized proposals on education of CRAs.Methods 141 clinicians were randomly sampled from tertiary hospital for questionnaire survey,using the 5-point Likert scale.The survey covers 4 levels,i.e.,the work attitude,professional knowledge and ability,communication skills,and project management capabilities,as well as 14 dimensions.Data processing and statistics were analyzed using SPSS 15.0 software.The attribute characteristics of the investigation subjects were analyzed using x2 of the contingency table,along with analysis of its correlation with the general satisfaction on CRAs.Results The mean values of the 12 indicators range 2.28 to 3.75,with low satisfaction in general.Among these indicators,satisfaction of the service attitude of the CRA,and of their familiarity with the pilot program and CRF completion axe the highest,respectively,74.04％and 61.70％.Satisfaction of the rest 10 indicators falls below 50.00％.The chisquare analysis showed no association between satisfaction and gender,education,job titles.The satisfaction is different(P＜0.05)between those trained and those not,while there exists a significant differences(P＜0.01)between those participating in different number of tests.Conclusion Clinicians have a low satisfaction on CRAs.It is recommended to strengthen the training,establish a CRA occupation certification system,and to strengthen the clinicians' emphasis and competency of clinical trials.These actions will normalize the industry of clinical trials and improve the level of clinical trials in China.