A shift was already beginning as the result of budgets to increase remote QA/QI activities when the COVID-19 pandemic crystallized the need for organizations to be able to ensure compliance with human subjects regulations and IRB determinations without conducting on-site visits. Implementation of single IRB for investigator-initiated research also highlights the need for more explicit QA/QI monitoring plans to be put in place and that involve a prominent role for coordinating centers (or lead study teams) in ensuring compliance. Attendees should be familiar with the basics of study auditing and monitoring before attending this session.
Review the differences between remote and on-site compliance reviews that need to be considered and addressed
Discuss how study teams play a key role in ensuring compliance, such as through self-audits or compliance reviews conducted by coordinating centers/lead study teams in the case of multi-site research
Share strategies and tools to facilitate effective remote compliance auditing