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QA/QI and Postapproval Monitoring Track
2019 AER Conference
Basic
Mary-Tara Roth, RN, MSN, MPH
Director, Clinical Research Resources Office; Assistant Director Human Research Protection Program, Boston University Medical Campus/Boston Medical Center
Leslie M. Howes, MPH, CIP
Director, Office of Regulatory Affairs and Research Compliance, Harvard T.H. Chan School of Public Health
Institutions and universities have changed policies and procedures to be in compliance with the revised Common Rule. Some of the new provisions decrease the oversight and administrative burden of the IRB while simultaneously increasing the investigator’s responsibility. QA/QI programs have long been instrumental in educating and auditing investigator sites to ensure compliance, and this is another opportunity. During this session, speakers and attendees will: