The Research On Quality Management In Monitoring Of Drug Clinical Trial

Drug clinical trial is a crucial step in new drugs development, which has asignificant role in the research and marketing approval of new drugs. The quality oftrials can directly affects the success of new drugs registration and application.Monitoring oversees a clinical trial process and is an important part of ensuring thequality of clinical trial. The goal of monitoring is to ensure that the process of trials inaccordance with the clinical trial protocol, standard operating procedures（SOPs）andcorresponding regulations. Meanwhile, monitoring also aims to protect the interests ofvolunteers in clinical trials as well as guarantee data accuracy and integrity.Monitoring has a critical impact on the quality control of clinical trials. By monitoring,we can find out the problems in the implementation of clinical trials timely, so as torectify and resolve them to improve the quality of clinical trials continuously. Thispaper discusses the major issues monitor found and analyze reasons, and to makerecommendations and measures to provide a reference for the clinical trial monitoringwork to improve the quality of clinical trials.In this paper, a total of836clinical trial monitoring reports are collected andclassified according to the types of drugs, phases in clinical trials and monitoringstage. The issues recorded in the monitoring reports are analyzed, summarized andaggregated into the record problems extracting table to compare the similarities anddifferences of problems occur in the implementation process of clinical trials betweendifferent types of drugs, different phases of clinical trials as well as the differentmonitoring stages. By subgroup analysis of recording problems in the monitoringreports based on frequency analysis and chi-square analysis, study records/CRFfilled untimely/incomplete, enrolled slow progress are the most common problems.Problems happened in different clinical trials vary because of different characteristicsof clinical trials.In the monitoring process, we should develop specific monitoring plans based ondifferent clinical trials characteristics. With the widely use of electronic data capture system, taking a risk-based centralized monitoring will be the future developmenttrend of monitoring. In addition, we can also establish monitoring guidancedocuments and management systems of monitors, promote clinical researchcoordinator (CRC) mode and other methods to improve the efficiency and quality ofmonitoring and the quality of clinical trials.