D14 - Ideas and Practices for Auditing of Single IRB Studies

Thursday, November 18, 2021

1:30 PM – 2:30 PM ET

Location: On-Demand

Single IRB is becoming commonplace in the human subjects' clinical trial enterprise. As institutions transition to roles as reviewing IRBs or relying institutions, they face new challenges with respect to ensuring appropriate oversight of the research and study team(s). QA/QI and postapproval monitoring programs will play a critical role in ensuring study teams are aware of their responsibilities, remain in compliance, and investigate areas of concern on behalf of the Reviewing IRB. This session will highlight strategies to effectively conduct audits of single IRB studies and demonstrate best practices through a mock audit of a multi-site ceded study.

Learning Objectives:

Gain familiarity of the applicable regulations and policies governing multi-site research and key challenges for oversight of studies using an single IRB
Using case studies, learn how to identify compliance concerns, including both regulatory and institutional, for a ceded study
Discuss practical considerations and best practices for conducting audits of single IRB studies and communicating with the single IRB

Presenter(s)

Lisa R. Buchanan, MAOM, CIP

DHHS, Office for Human Research Protections (OHRP)
Rockville, MD
JC

Julie Chamberlin, MPH, CIP, CCRP

Harvard T.H. Chan School of Public Health
North Providence, RI
Neala J. Lane, MS, CCRC

Indiana University
Indianapolis, IN