Identification errors in medical research: privacy at all costs?

Abstract

In laboratory medicine, a misidentified patient sample can lead to an incorrect tissue diagnosis, a potentially fatal blood transfusion error or other serious adverse events. Although well characterised in routine patient care, the overall impacts of misidentification errors in the clinical research setting are less conspicuous but potentially greater, with downstream effects that may extend beyond care at an individual level. When data discrepancies or queries arise in a clinical trial data then a data clarification form (DCF) is issued to the researcher by the overseeing trial coordinator or sponsor.