Abnormal Vital Sign Values Sample Clauses

Abnormal Vital Sign Values. Not all vital sign abnormalities qualify as an adverse event. A vital sign result must be reported as an adverse event if it is a change from baseline and meets any of the following criteria: • Accompanied by clinical symptoms • Results in a medical intervention or a change in concomitant therapy • Clinically significant in the investigator’s judgment It is the investigator’s responsibility to review all vital sign findings. Medical and scientific judgment should be exercised in deciding if an isolated vital sign abnormality should be classified as an adverse event. However, if a clinically significant vital sign abnormality is a sign of a disease or syndrome (eg, high blood pressure), only the diagnosis (ie, hypertension) should be recorded on the CRF.