2.1.1. Recording.
death, CRF
ADVERSE EVENTS, EVENT, CRF, DRUG EFFECT, ADVERSE EVENT, CONCOMITANT DISEASE
Suspected adverse events related to the study drug identified by the investigator that occurred in the subject during the study observation period will be recorded on the CRF’s adverse event form. And the investigator will determine the relevance of the adverse event to the product. The investigator will use the following definitions to assess the relationship between the adverse event and the investigational product: likely to be related: there is a strong temporal relationship between the adverse event and the investigational product, or reuse caused the adverse event, while being unlikely or significantly less likely to be of other etiology. Probably related: there is a strong temporal relationship between the adverse event and the investigational product, and there may be a similar or lesser correlation between another cause and the adverse event. Likely unrelated: There is a small or no temporal relationship between the adverse event and the investigational product and/or there is another more likely etiology. Unrelated: the adverse event was due to an underlying or concomitant disease or drug effect and was unrelated to the investigational product (e.g., no temporal relationship to the investigational product or the presence of another more likely etiology). It is the responsibility of the investigator to notify the Ethics Committee immediately in the event of death or serious injury to the subject. The investigator should keep on file all correspondence with the ethics committee regarding the evaluation of the event.