Avoid Protocol Deviations With Mobile Research Nurses

Protocol deviations can occur in clinical trials conducted at traditional sites as well as in those that employ decentralized clinical trial methods using mobile research nurses. The precise definition of a clinical trial protocol deviation varies by institution but is generally understood to mean any activity that does not adhere to the exact protocol laid out by the investigator. It could be anything from failing to obtain a signature to taking vital signs or a blood draw in the wrong order or outside the window to making a medication or dosing error.

Some research organizations distinguish between types of non-adherence based on the potential severity of the impact on the research subject’s welfare or study integrity, calling some instances of noncompliance protocol deviations and others protocol violations. Regardless of the nomenclature, any departure from the protocol is serious and, absent emergency or extenuating circumstances, must be avoided at all costs.