IRB Review of Phase I Healthy Research: Investigator and IRB Perspectives
Timelines are particularly critical in Phase I research involving healthy participants. A site’s relationship with their IRB can have a significant impact on whether study milestones are met.
Join our expert panel to learn about common pitfalls in Phase I study designs, pitfalls in IRB submissions, and strategies to help sponsors and sites plan for success. Our speakers draw on their experiences as IRB members and as Phase I research professionals to provide recommendations that sites and sponsors can use throughout the life of a study.
Learning Objectives:
- Identify common pitfalls in IRB review of Phase I healthy research
- Describe strategies for IRB collaboration and communication
- Outline what an IRB looks for when reviewing Phase I research involving healthy participants
Moderated By

Robert Romanchuk
BSHS, CIP, CCRC, CRCP
IRB Chairperson
Advarra
Presented By

Theresa Cummings
RN, DBA, CCP
Director, Clinical Protocol Office & Sr. Clinical Research Advisor to the Vice Chancellor of Research
UNC Lineberger

Randall Stoltz
MD, CPI, FAAFP
Physician Scientist IRB Member
Advarra

Pankaj Desai
PhD
Professor and Director, Drug Development Graduate Program, College of Pharmacy
University of Cincinnati
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour