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通过对一起临床试验出现的纠纷分析,提出临床试验的合同应加以规范,合同中除需明确规定申办者不仅应对参加临床试验的受试者提供相应保险,同时也需将保险的范围扩展至参加临床试验的研究者及其所在的医疗机构。另外,对临床试验中非预期的提前终止的项目,试验方案中必须有对受试者进行合理必要的后续治疗的预案,并将此可能的情形明确写入知情同意书中加以告知,以此尽可能地规避并减少临床试验中的纠纷。
Through the analysis of disputes arising from a clinical trial, the contract for clinical trial should be regulated. The contract stipulates that the sponsor should not only provide insurance to the participants who participated in the clinical trial, but also extend the insurance coverage to attend Researchers for clinical trials and their medical institutions. In addition, for unanticipated premature termination of clinical trials, there must be a premeditated plan for follow-up to patients that is reasonably necessary for follow-up and to include this information in an informed consent form As far as possible to avoid and reduce disputes in clinical trials.