Case analysis and management of research-related injury compensation of drug clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective:To propose suggestions on the prevention and treatment measures of drug clinical trial research-related injury from the research center perspective, and improve the protection of the rights of human subjects.Methods:Analyze three representative cases of drug clinical trial research-related injury compensation in a hospital, and put forward suggestions for the project management of the research center.Results:By reviewing informed consent forms and clinical trial liability insurance, actively participating in research-related injury treatment and implementation supervision, paying attention to safety information and risk monitoring, ethics committees, clinical trial institutions and investigators can play more proactive roles in protecting the rights and interests of human subjects.Conclusions:The research center could better control the risks of clinical trials and improve the protection of human subjects by strengthening the prevention and treatment measures for clinical trial research-related injury.