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  • Quality Assurance/Quality Improvement (QA/QI) in Human Subjects Research

    Offered in conjunction with the Harvard T.H. Chan School of Public Health Office of Regulatory Affairs & Research Compliance (ORARC), and serving as the 6th Annual QA/QI Boot Camp, this one-day workshop includes didactic and practical hands-on training for both new and advanced audiences.

    What Will I Learn?

    After attending this workshop, you will be able to:

    • Identify key features necessary to develop an effective QA/QI program
    • Understand the lifecycle of the audit, including for-cause and not-for-cause
    • Identify options for designing or improving upon the audit function
    • Provide constructive, supportive, and effective feedback to PIs and study teams
    • Incorporate training and educational opportunities into QA/QI activities
    • Identify and implement QA/QI services and study management tools appropriate for your institution
    • Discuss findings and possible corrective actions/best practices learned from a simulated audit of an investigator's files
    • Extend QA/QI service to evaluate and improve IRB/HRPP compliance
    • Identify which metrics to collect and how they can be used

    Who Should Attend?

    • QA/QI Directors, Specialists, Administrators
    • IRB Administrators who conduct or have an interest in QA/QI activities
    • Monitors
    • Investigators
    • Research Coordinators, Assistants, Project Managers
    • Others who are responsible for or have an interest in QA/QI or monitoring activities