QA/QI and Postapproval Monitoring Track

2019 AER Conference

11/11/2019 6:56 PM

C14 - Nuts and Bolts of Investigator Site Audits

Speaker(s)

• 

  Stephanie deRijke, RN, MSN
  

  Director, Clinical Trials Audit and Compliance, Emory University
  
• 

  Kelly Dornin-Koss, MPPM, RN, CIP, CCRC
  

  Director, Education and Compliance Office for Human Subject Research, University of Pittsburgh
  

Investigator site audits are the hallmark of postapproval monitoring and are integrated into many IRB QA/QI programs. This session will introduce attendees to the key concepts and practical strategies for developing investigator on-site audit activities while being mindful of the institution's research portfolio, whether primarily biomedical or SBER. During this session, speakers and attendees will:

Learning Objectives:

• Provide an overview of the investigator site review/audit process
• Address specific considerations of the investigator audit activity, including but not limited to: research portfolio (biomedical research vs. SBER), triggers for audits, sampling plans, grading/scaling on-site reviews, and who receives the report (the considerations will be compared/contrasted between multiple QA/QI programs)
• Discuss how audits can be an opportunity for investigator education
• Review practical and useful tools that sites can modify for their own use