药物临床试验合同管理疑难问题对策研究  

Countermeasure Study on Knotty Problems in Contract Management of Drug Clinical Trials

作　　者：苑丽敏[1] 库晓峰 Yuan Limin;Ku Xiaofeng(Beijing Tiantan Hospital,Capital Medical University,Beijing 100050,China;Beijing Huilongguan Hospital,Beijing 102202,China)

机构地区：[1]首都医科大学附属北京天坛医院,北京100050 [2]北京回龙观医院,北京102202

出　　处：《中国药事》2023年第6期652-658,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:分析药物临床试验合同管理中需解决的主要问题,并提出相应的对策建议,防范药物临床试验可能出现的风险。方法:查阅相关文献资料和法律法规,结合我国药物临床试验及药物临床试验机构合同管理现状,对药物临床试验合同进行分析研究。结果:合同主体、合同形式、合同涵盖内容包括受试者损害赔偿、试验费用、违约及终止、法律适用与管辖等,这些均是临床试验合同中的主要问题,是药物临床试验管理的重要环节。结论:建议建立合理的合同审核机制,加强审核队伍建设,关注易出现问题的条款或争议条款,科学、规范地管理临床试验合同。Objective:To analyze the main problems to be solved in the management of drug clinical trial contracts and put forward corresponding countermeasures and suggestions in order to prevent the possible risks of drug clinical trials.Methods:The relevant literature,laws,regulations and rules were consulted,and the clinical drug trial contracts were analyzed and studied in combination with the status quo of clinical drug trials and the contract management of clinical drug trial institutions in our country.Results:The contract subject,contract form and contents covered by the contract include subjects'compensation for damages,trial costs,breach of contract and termination,application of law and jurisdiction,etc.,which are the main issues in clinical trial contracts and the important links of drug clinical trial management.Conclusion:Clinical trial contracts can be managed in a scientific and standardized way only by establishing a reasonable review mechanism,strengthening the construction of review team and paying attention to the clauses prone to problems or controversial clauses.

关 键 词：药物临床试验 受试者损害赔偿 合同 疑难问题 对策 

分 类 号：R95[医药卫生—药学]