Study Director (associated with GLP study): Policy Term Definition

The individual responsible for the overall conduct of a nonclinical laboratory study. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (21 CFR Part 58 Subpart A58.3(m) and Subpart B58.33) The ORNcS Study Director provides support for both regulated and non-regulated scientific studies regarding regulatory oversight, summaries and protocols. The ORNcS Study Director will work with the PI, Director RSA and technical staff associated with given study.