Research 9B – Oops the PI’s Gone: What to Do Next!
Cynthia Dunn, Clinical Research Consultant, Crescent City Research Consulting, LLC
Wendy Portier, Independent Consultant
John Baumann, Associate Vice President for Research Compliance, Indiana University
- Discuss common oversight gaps that occur when the PI changes or leaves an organization
- Outline areas to consider when a PI changes, including: IRB review/approval, contract changes, sponsor notification, the Form FDA 1572, delegation of authority, training, and more
- Review key processes to address when a PI changes