Clinical Research Glossary

principal investigator principal investigator

CDISC

The main researcher who oversees a research study and makes sure it is done as planned.

Example of principal investigator in a sentence

The principal investigator is responsible for all parts of the research study.

More Info

The principal investigator (PI) oversees all the steps and actions that happen in the research study. The PI leads the research team and makes sure the study is done as written in the protocol.

The PI could be at a single site, overseeing all of the other staff at that location. The PI could also be overseeing the research study at many different sites.

There can be other researchers working on the study called investigators, co-investigators, or study doctors. In the US, the FDA refers to the PI as a clinical investigator.

Other info to think about when joining a study

You will most likely see the word “principal investigator” on official study documents like the consent form and the study protocol.

The principal investigator is fully responsible for all parts of the research study. You can ask for the principal investigator’s contact information so you can reach them if you have any questions or concerns about the study.

Version 3.0 September 2025

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