Reporting Abnormal Laboratory Findings Sample Clauses

Reporting Abnormal Laboratory Findings. The investigator is responsible for reviewing laboratory test results and determining whether an abnormal value in an individual study subject represents a clinically significant change from the subject’s baseline values. In general, abnormal laboratory findings without clinical significance (based on the investigator’s judgment) are not to be recorded as AEs. However, abnormal laboratory findings that result in new or worsening clinical sequelae or that require therapy or adjustment in current therapy, are considered AEs. Where applicable, clinical sequelae (not the laboratory abnormality) are to be recorded as the AE. An abnormal laboratory test result must be reported as an adverse event if it is a change from baseline and meets any of the following criteria:  Associated with clinical symptoms  Results in a medical intervention (eg, potassium supplementation for hypokalemia or iron replacement therapy for anemia) or a change in concomitant therapy  Clinically significant in the investigator’s judgment