To provide reference for the compliance management of sponsors and research institutions in drug clinical trial cooperation.

Based on the typical cases of drug clinical trials in Chinese Judgment Documents Online, this paper studies the legal risks, causes and countermeasures in the process of drug clinical trial cooperation from both macro and micro perspectives.

Overall, violations of drug clinical trial cooperation are probably subject to civil liability, administrative penalties, and criminal sanctions. At the micro level, both sponsors and research institutions generally neglect to review the clinical trial contracts, improperly manage clinical trial quality, and neglect subject protection. At the macro level, the legal policies of drug clinical trials are non-systematic, and the supervision of drug clinical trials is becoming stricter.

The sponsors and research institutions should adapt to the new requirements under the new policy, improve the main responsibility, and pursue higher standards of compliance requirements, in order to ensure the safety of subjects in clinical trials, while maximizing their legitimate rights and interests, thus preventing legal risks.