Electronic data quality control strategy in clinical research / 中华医学科研管理杂志

ABSTRACT

Objective To establish a method for data quality control of clinical research data based on electronic data capture (EDC) system.Methods After analyzed the specific characteristics of EDC's workflow process,and also referred to international data management guideline,we established the data quality control strategy by summarizing actual data quality control experience of data management department in Peking University Clinical Research Institute.Results Application of EDC has changed traditional clinical research process,therefore EDC data quality control strategy should be built according to its own process flow,namely,selecting the appropriate EDC system,reasonable design and build electronic case report form (eCRF),standardization research center / user management processes,timely and accurate on line eCRF filling up,accurately capturing/docking ex ternal electronic data,planned data monitor and auditing,timely and efficient query management,strictly data locking and unlocking operation process,and strict electronic record life cycle monitoring.Conclusions At present time,clinical research in China is still in the earlier stage of the transition from traditional paper-based data collection (PDC) to EDC.Establishing and applying particular quality control strategy will optimize the process and results of data quality control.