Problems found in self-inspection of drug clinical trial in an institution and discussion on management measures
Objective Analyze the problems collected from the self-inspection of drug clinical trial data of an institution,explore the causes of the problems in the process of clinical trial,and put forward suggestions and views to improve the quality of clinical trial,providing reference for project management and other institutions.Methods 156 items were collected by self-inspection of of an institution,then classified by the"Key points and principles of drug registration verification(drug clinical trial)(trial)",and then statistics and analyzed them.Results 130 items had 1 069 unqualified items that violated the key points and judgment principles of drug registration verification,among them,there were 132 unqualified items(12.35%)in terms of clinical trial license and conditions;799 unqualified items(74.74%)in terms of the implementation process of clinical trials;61 unqualified items(5.71%)in terms of the management of experimental drugs;46 unqualified items(4.30%)in terms of the management of biological samples.Conclusion This study showed that problems of the instition in the implementation process of clinical trials,licensing and conditions of clinical trials accounted for a large number of problems.It is suggested that it should improve the quality control mode,carry out the self-inspection of clinical drug trials,and implement information management,which has referential significance for improving the quality of drug clinical trials.
Drug clinical trialProject self-inspectionQuality control
万方数据
维普
