PI Academy: Investigator Responsibilities in FDA Regulated Research

The WVCTSI Principal Investigator Academy will host a special presenter from the U.S. Food and Drug Administration on March 11.  Dr. Cynthia Kleppinger, senior medical officer from the Good Clinical Practice Assessment Branch within the Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, will present “Investigator Responsibilities in FDA Regulated Research”. This presentation will give an in-depth overview of the Principal Investigator responsibilities for a clinical investigation, FDA expectations when they review research records, and how to prepare for a successful regulatory agency inspection. Case examples and enforcement options will be included.

This event will take place from 2 to 3 p.m. on Thursday, March 11. RSVP here. Questions can be directed to Debbie Lee at debbie.lee@hsc.wvu.edu.