Research On Quality Management Of Drug Clinical Trial In Stitutions Based On ISO9001:2015 Standard

ObjectivesTo investigate the domestic and international research status of Quality Management and the its application in drug clinical trial institutions(i.e.,institutions)through literature research,analyze the core ideas of quality management of institutions based on ISO9001:2015 standards(i.e.,ISO9001),establish a evaluation system according to ISO9001 that could provide references for the evaluation of the quality management ability of newly filed institutions,and promote the further improvement of the quality management of institutions.Methods1.Literature analysis method:according to the research purpose,literatures,policies and regulatory documents related to the quality management of drug clinical trials at home and abroad were collected through the database,library,network and other channels,and the core ideas of the quality management of institutions based on ISO9001 were elaborated.2.Delphi expert consultation method:specific evaluation indexes of each dimension are designed according to the ISO9001,ICH-GCP and China GCP,which were then formulated to an questionnaire that to be used for a two-round consultation with experts in the field of drug clinical trials quality management.A quality management evaluation system of institutions was established based on comments received.3.Analytic Hierarchy Process(AHP):multiple comparisons of evaluation indexes were done by experts invited for consultation independently,and all evaluation indexes were then prioritize at all levels using AHP.4.Questionnaire survey method:according to the established evaluation system,a questionnaire regarding the construction status of the quality management system of institutions was prepared and used in the empirical research on 13 Class Ⅲ Western medicine hospitals in GD Province,preliminarily verifying the scientific nature of established system.Results1.The current status of the application of ISO9001 in institutional quality management was analyzed and 7 quality management principles corresponding to the core content of institutional quality management were expounded.2.A evaluation system of institutions based on ISO9001 was determined through a two-round expert consultation,and evaluation indexes,together with its weight at all levels,including 4 first-level indexes,15 second-level indexes and 49 third-level indexes,were confirmed using AHP.3.Empirical study on the quality management evaluation system of drug clinical trial institutions.The results given by questionnaire shows that the ranking of the 13 institutions is positively correlated to the number of the drug clinical trials undertaken.4.Suggestions for the quality management of drug clinical trial institutions based on ISO9001 were proposed.ConclusionThe experts’ opinions on the evaluation indexes of institutions established tend to be consistent,that they are authoritative,scientific and practical,and can be references for evaluating the comprehensive quality management ability of institutions.Through the weight analysis of indicators at all levels,it is believed that it is the support from the hospital that has the greatest impact on the improvement of the quality management ability of institutions.The empirical research results show that those GD institutions surveyed have established a clinical trial quality management system and are equipped with relatively fixed personnel for management,however,at the aspect of prevention and correction,such as problem identification,cause analysis and continuous improvement,still need to be further strengthened.