The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research

Clinical Research Resources Office, BMC/BUMC

Mary-Tara Roth, RN, MSN, MPH, Director, CRRO

Register via the The Principal Investigator Role webpage.

This course occurs quarterly; registration for December closes at 8 am, December 13, 2023. It will next be offered on March 5, 2024.


It covers the responsibilities of PIs and FDA sponsor-investigators; explains the purpose of and criteria for IRB review; discusses monitoring, evaluation, and reporting of adverse events and unanticipated problems; identifies protocol adherence and safety plan strategies; and presents best consent and screening practices; and study documentation best practices to meet IRB requirements and support high quality research.

Successful completion fulfills the PI GCP training requirement for 3 years.

Course duration: 3.5 hours