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Question:

请教关于研究者签署财务披露声明的问题,签署时间节点和频率,以及使用何种语言?目前只接触过英文版本,有使用中文版的情况吗?

Answer:

签署研究者财务披露声明的要求源自美国FDA 21 CFR Part 54 “FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS” (可参见https://www.fda.gov/scienceresearch/specialtopics/runningc)该信息作为FDA判断研究者是否存在利益冲突,进而判断试验数据是否真实可靠的一个考虑因素。

该声明签署的时间节点和频率可参考21 CFR Part312, C(4) “Financial disclosure information. Sufficient accurate financial information to allow the sponsor to submit complete and accurate certification or disclosure statements required under part 54 of this chapter. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.” 

为确保收集的信息完整可靠,必要时可以考虑提供中英文对照供研究者充分理解该声明的内容和目的。