Here, rules (or limits) may be in place which govern such decisions; these may be based on a previously obtained understanding of the relevant risks and they usually lead to predetermined actions or expected outcomes. 同样可能存在管理此类决策的规程(或限制),可能基于先前对相关风险的了解,通常会导致预定的行动或预期结果。--ICH Q9 《风险管理》