ABSTRACT
China has started to accept the overseas clinical trial data about drug and medical devices, and the data in accordance with the requirements can be used to register in China. To do this work well, we should consider four key dimensions: data acceptance principle, data quality and reliability, data evaluation usability and data international difference. Among them, the authenticity, integrity, accuracy and traceability of data are the main factors to determine the quality reliability of data. Receiving data from overseas clinical trials about drug and medical devices will be conducive to the establishment of international mutual recognition system for clinical trial data, and to enhance the importance of data management in domestic clinical trials, and to promote the formation of quality management system on clinical trial data.
ABSTRACT
This article discussed the development, challenge and solution for the front page of inpatient medical record based on DRGs (diagnosis related groups).It will facilitate the stakeholders' understanding, unifying the standard of data, building quality control system, improving the quality of the front page of medical record.Thus, the information in the front page will contribute to the scientific evaluation of health service ability and quality for hospital.