RESUMO
OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.
RESUMO
OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.