Research On The Factors,problems And Countermeasures Of The Quality Control System In Drug Clinical Trial Institutions

Objective:To analyze the development trend of quality management in domestic drug clinical trials,explore the elements of drug clinical trial institutions to establish a quality control system.In view of the drug clinical trial institution problems in the process of clinical trials,combined with the research progress of clinical research coordinators at home and abroad,discusses the feasibility of clinical research coordinator involved in quality control.In order to improve the quality control of institutional drug clinical trials in China,reasonable Suggestions are put forward.Methods:The research was conducted in three stages.In the first stage,literature analysis was adopted.Based on the literature review and the relevant regulations and technical specifications of drug clinical trials published on the website of National Medical Products Administration in the past five years,this paper analyzed the development trend of quality management in domestic drug clinical trials,and made a comparative analysis of the status quo of clinical study coordinators at home and abroad.The second stage aimed at constructing the quality control system elements of drug clinical trial institution,according to the necessity of setting up the full-time staff,the scope,content and frequency of quality control inspection,the key links to be paid attention to,the records and reports of quality control,and the understanding of quality management inspection,a questionnaire was constructed.Adopting the method of objective sampling,the managers of the office of the national drug clinical trial institution and the medical staff who had participated in the drug clinical trial were taken as the research objectives,the web-based questionnaire was distributed to the Wechat group to obtain the answers to the relevant questions,and the received questionnaires were analyzed by using Excel and SPSS 17.0 statistical software.In the third stage,based on the results of the questionnaire,the feasibility of the interventional clinical research coordinators in the quality control of drug clinical trials was studied,and the prospect of strengthening the quality control construction of clinical trial institutions and the career development construction of clinical study coordinators was proposed.Results:Received a total of 140 valid questionnaires.More than half of the respondents thought it was necessary to set up a full-time quality controller;the proportion of all respondents to the scope,content and frequency of quality control inspection and the key points to be paid attention to were relatively average;52.9%of respondents thought that the proportion of medical records and CRFs should be determined according to the number of cases completed;62.9%respondents thought that general or individual problems or slight program deviation should be directly issued by the quality manager,and the important problems such as system problems and program violation that require the researcher to rectify within a time limit should be handed over to the director of the office or the quality manager in charge for examination and verification;the vast majority of respondents believed that institutional quality management did not duplicate the supervision and audit of the sponsoring organization.The problems found by the clinical research coordinators in the drug clinical trials mainly include the implementation of clinical trials,the recording of clinical trials and the management of trial drugs.The quantities and severity of the problems found by clinical ressearch coordinators were different from the institution.Conclusions:The elements of quality control system in drug clinical trial institution including the establishment of full-time quality controller,scope of the quality control checks(include all projects),institutional quality control plan(include quality control program,the time and frequency,selective cases and emphasis,etc.)the ratio and quantity of inspection records and CRFs(should be decided by the cases of the project completion),quality control records and reports(general,individual problems or slight plan deviation issued directly by the quality manager,important issues such an system problems,protocol deviation which should be made corrections within a fixed period of time by researcher submitted to institutional officer or quality director.etc.).Clinical research coordinators play an important role in the quality control system of drug clinical trials.However,compared with the ability and level of the quality control administrators who are required by the institutions,there is still a certain gap.At present,clinical research coordinators cannot replace the quality control administrators.