The Role and Responsibilities of the Investigator in Ensuring Quality Laboratory Data

Abstract

Due to the importance of laboratory analyses in clinical studies, whether for toxicity monitoring, assessment of plasma levels, or efficacy assessments, a suitable infrastructure should be created at the investigational site to ensure adherence to the specified protocol requirements for these laboratory parameters. This will ensure meaningful and quality data at the end of the study. Thus, there are certain requirements to consider when selecting investigational sites such as feasibility, equipment, expertise, and personnel. This article will discuss the ways in which a sponsor can develop this infrastructure, the role and responsibilities of the investigator, and the means of maintaining the infrastructure.