Before revision: An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.ICH GCP All AEs in patients participating in clinical trials are recorded in the case report form and medical notes and reported at the end of the study.
After revision: An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.ICH GCP AEs in patients participating in clinical trials are recorded in the case report form and medical notes and reported at the end of the study.