Investigation and analysis on the management status of document control in drug clinical trial institutions
Objective:To investigate the status and potential problems in the management of document control in clinical trials,providing reference for the management of document control in drug clinical trial institutions.Methods:Questionnaire survey was conducted in 71 drug clinical trial institutions in China.The questionnaire focused on the basic situations,the scope,the method,problems and difficulties that are involved in the management of document control in drug clinical trial institutions and clinical trial programs.Results:The survey included 71 drug clinical trial institutions located in 13 provinces,municipalities and autonomous regions in China.A total of 71 questionnaires were obtained.The survey found that 94.37%of the institutions have achieved the management of document control,25.37%have applied electronic system in the management of document control,≥95%of respondents considered that the paper records should be controlled management and that was taken as unique and irreplaceable included tumor evaluation form,subject diary card and drug management form.At present,there are problems in the management method of document control,including heavy workload,impossibility of closed-loop control and poor confidentiality of electronic controlled system.Conclusion:Through the analysis of the survey results and the importance of various documents in clinical trials,the controlled documents are proposed to divide into three controlled management levels of general controlled documents,important controlled documents and core controlled documents.According to the classification of controlled documents,the survey makes corresponding recommendations in controlled management,identifying priorities in the management of document control and improving the efficiency and quality of document management in clinical trials.
drug clinical trialdocument controlcontrolled managementquestionnaire survey
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