Taming the regulatory beast in federal and other multi-site trials
Join us for an hour-long seminar featuring a panel discussion, presentations, and a Q&A session.
- Julianne Feola, PhD, CCRP, Multisite Program Manager, Clinical Trials Office, Masonic Cancer Center
- Courtney Jarboe, MS, MA, CIP, HRPP Assistant Director, IRB, Human Research Protection Program
- Daniel Weisdorf, MD, Professor of Medicine, Division of Hematology, Oncology and Transplantation; Deputy Director, Clinical and Translational Research Services (CTRS) core Director, Clinical and Translational Science Institute
- Navigate NIH/common rule sIRB requirements
- Understand responsibilities as lead PI of a multi-site trial (IRB and FDA)
- Understand what FDA will expect from Sponsor-Investigators:
- Differences between what Sponsor-Investigators have to have when they are the "sponsor" or overall responsible party for the study - and what they have to make sure every one of study "investigators" also has
- In terms of documents to demonstrate proper management of the clinical tria
Hosted by the Clinical Research Support Center (CRSC) and CTSI's Research Education, Training, and Career Development core (CTSI-Ed).
Part of the Multisite Trial Development and Implementation Miniseries. This seminar is targeted toward research faculty who are preparing to conduct multi-site trials, but all are welcome to attend.