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Question: ArrayDuring the hospitalization period, the subjects strongly requested to be discharged and transferred due to their aversion to the poor hospital environment. Do they need to report to SAE? How to handle this situation
Answer: Regarding the SAE report, please refer to the previous reply. The reasons for hospitalization/transfer are clearly recorded in the medical record. Researchers can communicate with the subjects to clarify the pros and cons according to the protocol requirements. If the plan clearly stipulates the need for hospitalization, but the subject cannot comply and there are no other solutions, the subject can be considered to withdraw from the trial.