Investigator
Also referred to as Principal Investigator (PI), the person who carries out the study as planned, as a whole or at an individual site. The Food and Drug Administration (FDA) and the International Council for Harmonisation (ICH) defines Investigator as follows:
Investigator (FDA): An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. FDA: 21 CFR 50.3, Definitions
Investigator (FDA IDE): An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. FDA: 21 CFR 812.3, Definitions
Investigator (FDA IND): An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Sub-investigator includes any other individual member of that team. FDA: 21 CFR 312.3, Definitions and Interpretations
Investigator (ICH GCP): A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. ICH GCP, 1.34
« Back to Glossary Index