International Medical Device Regulators Forum - 10 October 2019
This document supersedes an earlier version produced under the Global Harmonization Task Force (GHTF) with the same title in February, 2010 (GHTF/SG5/N3:2010). What is a clinical investigation? A clinical investigation is defined as any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device. The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.