Clinical outcomes research of traditional Chinese medicine——introduce registry intensive hospital monitoring study protocol of traditiona Chinese medicine injection's safety

Abstract

Traditional Chinese medicine (TCM) injection's safety problems has been paid attention for the country and people, TCM injection's labels described the adverse reactions always shows "unclear" or blank, especially the adverse drug reactions(ADR) rates hardly reported. To save the problem, large-scale safety surveillance of TCM injection research is very important. The article introduces the research aim, research type, simple size, outcomes and ethic problem during make the plan. It is a multi-center, large sample size, registry research program about TCM injections safety monitoring. The aim is to get the ADR's rate of TCM injections. According to the "three rules" , each of the TCM injection will be observed for 30 000 cases which are inpatients. The research adopt to using the barcode system and hospital information system(HIS) & laboratory information management system(LIS) to make sure enroll all patients. Case report file (CRF) is used for record patient's information which contained 3 types(A, B, C) tables. Most of people just need to fill table A, and the patient need to fill table B when they have ADR. The outcome of the research is severe ADR. Abide by the international ethical principle to keep the patient's right.