PI (Principal Investigator or Primary Investigator)

The Primary or Principal Investigator (PI) is the individual responsible for executing the clinical trial in compliance with the policies of the applicable regulatory bodies, such as the FDA, IRB, and DHHS. The PI is ultimately responsible and accountable for study conduct.

While the PI does not have to be a physician, a qualified physician or dentist must be listed as a sub-investigator in that event.


Responsibilities of the PI include:

  • Supervising the conduct of the study in compliance with the signed investigator statement, investigational plan, and applicable regulations.
  • Protection of the rights, safety, and welfare of study subjects.
  • Ensuring IRB review, approval, and appropriate reporting.
  • Informed consent is adequately obtained.
  • Control of drugs under investigation.
  • Adequate and appropriate record keeping and retention.
  • Completion and submission of investigator reports to the sponsor that include progress reports, safety reports, final report, and any financial disclosures.

Source: U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, & Center for Devices and Radiological Health. (2009, October). Guidance for Industry- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects