Investigation and analysis of the awareness degree of clinical trial liability insurance for investigator-initiated trials
Investigator-initiated clinical studies often use marketed drugs,medical devices,or diagnostic reagents to explore new uses,indications,and combinations,which are inherently exploratory and innovative,and inevitably come with certain unknown risks."Clinical trial liability insurance"is a way to reduce the risk of payout and financial burden caused by potential damages in clinical research.In order to understand the knowledge of domestic IIT researchers and managers about this insurance,the author conducted a survey by means of an online questionnaire among 201 respondents from medical institutions in 25 provinces to understand their knowledge about subject damage compensation,the content of clinical insurance policies,the amount of clinical insurance,the scope of policy exemptions,and the training of the insurance process,respectively.From the survey results,it can be seen that there is much room for improvement in the meaning of purchasing clinical liability insurance for IIT projects and how to effectively prevent and control the risk of damage compensation through insurance,the need to strengthen the gatekeeper of insurance amount and duration,and the payout ratio,as well as the understanding of the insurance claim process in China.
NETL
NSTL
万方数据
维普
