Abstract: Objective To conduct an in-depth analysis of drug clinical trial illegal punishment system in the United States, so as to perfect legal liability system of drug clinical trials in our country. Methods Through the review of the laws and regulations of the United States and the guidance of the law, the paper analyzed the applicable situation and punishment of different subjects' legal liability, and put forward some suggestions. Results The study found that the legal system of clinical trials in U S clearly stipulated the key responsible persons(RPs), including sponsors, investigators and IRBs. For minor violations or fraud, FDA usually communicates with RPs by letters, disqualification process or the AIP process. For serious criminal or counterfeiting will face withcriminal penalties. Conclusion China should identify the key responsible person, and promote the responsibility of RPs and establishment of readily accessible transparency system. Furthermore, we should guide RPs to solve minor problem by flexible communication process. The rigid criminal penalty system and the industry blacklist should be effectively established.

Key words: clinical trials, responsible person, legal liability, criminal penalty