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Question: At the baseline examination of the patient, all laboratory test indicators were normal. Some laboratory test indicators showed abnormalities after medication. Do researchers need to record medical judgments that have clinical significance and are believed to be related to the underlying disease (target indication), so there is no need to report adverse events
Answer: According to the definition of GCP, "Adverse events refer to all adverse medical events that occur after a subject receives the investigational drug, which can manifest as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug. If the situation described in the question is judged by the researcher not to be an adverse event (such as abnormal laboratory test indicators that are part of the natural course of the disease under study), the researcher needs to record the reasons for their judgment.