新药临床研究阶段需要患者或志愿者签定知情同意书。为了更好地发挥知情同意书对受试者的保护作用，体现科研项目的科学伦理性，研究者有必要精心设计知情同意书。针对目前知情同意书设计中存在的告知不全面、设计欠合理等问题进行简要分析，并介绍如何正确地设计与应用知情同意书。

Vietnam is the one of developing countries in Sout heast Asia. In Vietnam, traditional Chinese medicines (TCMs) is widely accepted in the mainstream of local pharmaceutical market, and also covered by government reimbursement. As a result, Vietnam is one of the target countries for TCM to l aunch in the market. Supported by the National Eleventh “Fiveyear” Program, Tasly has carried out studies on the application of Yangxue Qingnao Granule in V ietnam. The article has given a brief review on technical requirements of the eva luation of Chinese Proprietary Medicine and indicated relevant ideas and views o f the application as an example of prescription drug application in Vietnam. The article has provided good experience for Chinese Proprietary Medicine manufactu rers in our country to enter Vietnamese medical market, and also established the foundation for the development of Chinese Proprietary Medicine in Vietnamese ma rket.

国家“十一五”科技支撑计划资助项目(2006BAI11B00)