Reference ranges are important criteria to evaluating your patient’s laboratory results. Covance provides reference ranges that are age and gender specific and represent a heterogeneous clinical trials patient population. Covance uses a series of flags to represent the meaning of a patient’s test results which fall outside of the reference range.
If a patient’s value triggers a flag, it will print on the laboratory report. Your sponsor may request additional flags. These will also print on the laboratory report.
In order to ensure timely assessment of patient care, regulations require immediate reporting of laboratory values with potentially critical implications for the patient. For all HP and LP flags, Covance calls the investigator site and requires a live voice to receive these values and read back. Notification of other flags are determined by the sponsor of the protocol.