Optimization Of Clinical Trial Data Quality Control System For Class Ⅲ Medical Devices In XJ Hospital

Clinical trial of medical devices has become one of the important signs to measure whether a hospital has the level of modernization.Clinical trial data is the most important evidence to demonstrate that medical devices are safe,effective and approved for marketing.And good data management is the key to ensuring the quality of clinical trials.Management leads to quality,quality leads to benefits" is the specific application of clinical trial data management.Currently,there are some problems in the industry such as non-standard data management,and some data are fraudulent or missing."722" storm has exposed the clinical trial process records,clinical examination and laboratory test data and solutions such as violation of up to28.1% and 12.0%,and about the quality of clinical trial data is scattered in all kinds of current standards,regulations and other documents.Therefore,how to standardize,legalize and efficiently manage clinical trials of medical devices has become an issue that cannot be ignored,and XJ Hospital is also facing such problems at present.This paper takes the quality management of clinical trial data of class Ⅲ medical devices in XJ Hospital uses methods such as literature review and case analysis.Learn from the theory of total quality management,PDCA cycle theory and the theory of data quality management system,using the pareto diagram class Ⅲ medical devices quality management tools to analyze XJ hospital clinical trial data quality control system structure present situation and the data management present situation and main problems of the hospital.It is found that the organization structure,institutional system,operation process,personnel training management and electronic data acquisition system imperfect.Based on total quality management theory and PDCA theory,an optimization plan for clinical trial data quality control of class Ⅲ medical devices in XJ Hospital was proposed,which focused on the design of data quality monitoring in the whole process of the trial.It puts forward the optimization from the aspects of adjusting organizational structure,increasing personnel allocation,electronic data platform,data security prevention and control,equipment and facilities updating,and puts forward from the aspects of establishing the steering committee,strengthening the construction of talent team and increasing the financial support for data management.This study not only has important practical guiding significance for XJ Hospital in clinical trial data management of class Ⅲ medical devices,but also has certain reference value for domestic peer hospitals with clinical trial qualification.