Although EU inspectors and clinical assessors are mandated to identify and act upon ethical issues, regulators lack guidance on how this can be done. Hence, we propose a four-step regulatory approach on ethically relevant GCP violation findings. The first step is identification of the ethical issue. Next is analysis [i.e., identifying the gravity (intensity or severity) and the magnitude (amount and duration) of the ethics violation as well as the responsible person(s) or entity or entities]. The third step is evaluation, (i.e., the process of deliberating to determine the significance of the ethics violation, with the intention of identifying the most reasonable sanction and/or corrective or reparative action). Last is decision-making or the process of choosing and implementing a regulatory course of action.

中文翻译：

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对违反道德规范的GCP行为的监管制裁。

尽管欧盟检查员和临床评估员被授权查明道德问题并采取行动，但监管机构仍缺乏有关如何做到这一点的指导。因此，我们针对与道德相关的GCP违规发现提出了四个步骤的监管方法。第一步是确定道德问题。接下来是分析[即，确定违反道德规范的严重程度（强度或严重性）和严重程度（数量和持续时间）以及责任人或实体。第三步是评估（即，为了确定最合理的制裁和/或纠正或赔偿措施而进行的研究，以确定违反道德规范的重要性的过程）。最后是决策或选择和实施监管措施的过程。