English to Russian Medical Medical (general)

Diagnoses versus signs and symptoms:
 Each event should be recorded to represent a single diagnosis. Accompanying signs (including abnormal laboratory values or ECG findings) or symptoms should NOT be
recorded as additional AEs. If a diagnosis is unknown, sign(s) or symptom(s) should be recorded appropriately as a pretreatment event(s) or as an AE(s).
Laboratory values and ECG findings:
 Changes in laboratory values or ECG parameters are only considered to be pretreatment events or AEs if they are judged to be clinically significant (ie, if some action or intervention
is required or if the investigator judges the change to be beyond the range of normal physiologic fluctuation).
 If abnormal laboratory values or ECG findings are the result of pathology for which there is an overall diagnosis (eg, increased creatinine in renal failure), the diagnosis only should be reported appropriately as a pretreatment event or as an AE