Which espects should be mentioned when recording a AE? And what should the investigator do if the AE is serious?
When recording an adverse event (AE), it's important to include the following aspects:
Type of AE: This refers to any unfavorable and unintended sign (including abnormal laboratory findings not meeting the criteria for an AE) that occurs during or after treatment with the test article.
Onset: The date and time at which the AE occurred.
Severity: The severity of the AE, ranging from mild to severe.
Outcome: Whether the AE was resolved, ongoing, or resulted in death.
Relationship to study product: Whether the AE was related to the test article or not.
Action taken: Any actions taken by the investigator to address the AE, such as administering medication or providing supportive care.
If an AE is serious, defined as one that results in any of the following outcomes:
Death
Life-threatening events
Inpatient hospitalization or prolongation of existing hospitalization
Persistent or significant disability/incapacity
Conception
Birth defects
Other medically important condition The investigator should take appropriate action to address the AE, including informing the sponsor and institutional review board (IRB) immediately. They may also need to stop further dosing of the study drug until the cause of the AE has been determined and appropriate action has been taken.
