Qualifications of Investigators for Clinical Investigations Conducted under an Ind: A Discussion Paper

Abstract

Selection of qualified investigators is an essential component of each clinical drug development program. A monitor executes the sponsor's regulatory responsibility to select qualified investigators. However, sponsors and monitors must decide, in a manner consistent with the regulations, what constitutes appropriate qualifications for investigators under a specific Investigational New Drug (IND) application. This paper summarizes information from regulations, guidelines, and other sources in order to help sponsors and monitors properly address this important issue for their clinical investigations