Relevant follow-up information must be
submitted as soon as the information is available. For an individual case that
was submitted, examples of the types of information that trigger the follow-up
safety reporting requirements include the following
当相关的跟进信息可获得时，应当及时提交。对于一个已提交的SAE事件，能够触发后续安全报告需求的信息类型包括以下四种情况：
The following information generally would not trigger the requirement for a follow-up safety report (Refer to Safety Assessment for IND Safety Reporting Guidance for Industry)
以下三种类型的信息一般不会需要跟进安全报告 (参考Safety Assessment for IND Safety Reporting Guidance for Industry):
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Quality Solutions to Quality Management
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