这里的AE （adverse event)是对谁呢？实验对象，还是接触的人，还是试验结果？ 8.3.5.3. Occupational Exposure An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant’s care. Appendix 里对adverse event的定义是： 0.3.1. Definition of AE AE Definition • An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. • NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
8.3.5.3. Occupational Exposure An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant’s care.
Appendix 里对adverse event的定义是： 0.3.1. Definition of AE AE Definition • An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. • NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
Resource: C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf (tghn.org) Section 8.3.5.3