Common problems and improvement strategies of quality management in investigators-initiated clinical trials
Objective:To analyze the common problems in the quality control process of investigator-initiated clinical trials(IIT)and discuss the solutions and improvement strategies.Methods:By summarizing the key points of quality management of IIT,the common problems existing in the quality management process of IIT were analyzed,and suggestions were put forward to solve these problems.Results:The key points of quality control of IIT mainly include process standardization,subject protection,data management and data traceability,implementation quality,and sample management,etc.By summarizing the problems found in the management practice and supervision and inspection of the author's medical institution,the common problems could be divided into two levels,the implementation of the researcher and the subjective cognition.Combined with the key points and common problems of quality management,the author suggested that the quality of IIT management should be improved by setting scientific and unified quality control standards,implementing hierarchical quality control,strictly checking the internal review,and establishing and improving the training system.Conclusion:Quality control is of great significance to improve the quality and standardization of IIT,and medical institutions can establish and optimize the internal quality control management system based on the key points of quality management and common problems,so as to achieve the goal of improving the standardization and quality of IIT.
investigator-initiated clinical trialsquality administrationquality controlsupervision and inspectionstandardization
NETL
NSTL
万方数据
