The Research About Quality Control And Relevant Factors Of Projects On Clinical Trials In A Certain 3^rd-Level Hospital

Objective: To analyze the influence factors of quality control for drug clinical trials and to put forward to the corresponding countermeasures.Methods: Heoretical analysis,empirical analysis,qualitative analysis and quantitative analysis methods by questionnaire was used this study in order to explore relevant factors,which affect quality control for drug clinical trials selected by stratified random methods in The First Affiliated Hospital of Xinjiang Medical University.The questionnaire are made up of 7 factors,obtaining informed consent,researcher?s adherence,data record,checking of unusual values in laboratory examination,subjects compliance,drug management,and adverse events processing.Results: The alpha coefficient of consistency of seven quality control factors(acquisition of informed consent,compliance of researchers,data record,reexamining of abnormal laboratory values,compliance of subjects,experimental drug management,disposing of adverse events)was more than 0.8 in this study,and it was suggested that the questionnaire had better reliability,which had better content validity.The results evaluated on some indicators such as respondents,gender,age,and job title,showed that the constituent ratio of male and female was similar(P>0.05);the ratios of ages<35,35-45and>45years had significant difference(P<0.05);the respondents of vice-senior title and above,and education background of master's degree and above were relatively more(P<0.05).Thus it can be found that the most researchers engaged in drug clinical trials had higher education background and rich clinical experience as well as specialized skill ability.The results evaluated on respondents,gender,age,job title and education background showed that the researchers of the older had the superiors in “acquisition of informed consent” and “adherence of researchers” as well as the higher job title had the superiors in “acquisition of informed consent” and “compliance of subjects”,but there were no significant effects of gender,education background on quality control in clinical drug trials.Conclusion: Researchers was not as well in the "compliance,data records,laboratory outlier review,test management,the processing of adverse events " as an experience doctor,which means the researchers not only know about drug clinical trial management specification(GCP),but more importantly take the specification into practice.However,it is easier to obtain the informed consent of subjects for the researchers with the increase of age and title,because of more trust for the better doctor-patient communication to improve patients? compliance.Thus the age,educational background,professional title,age of researchers for the quality control of drug clinical trials are not the decisive factors.A good researcher needs more comprehensive knowledge of GCP,the accurate understanding of research plan and strict implementation to perform a safe and orderly protection of rights and interests of the subjects in clinical trials.Therefore,for all researchers,GCP training is necessary,for strict compliance with GCP specifications.