2019 Research Compliance Conference

Investigator Initiated Trials (IITs): Addressing the Challenges of Auditing IITs for Compliance and GCP

  • Investigator Initiated Trials (IITs): Addressing the Challenges of Auditing IITs for Compliance and GCP

    Wendy Portier, Independent Consultant, Kelly Willenberg and Associates. Gabriella Neff, Research Compliance Officer, Moffitt Cancer Center.

    June 11, 2019

    • Identify the unique regulatory and operational challenges of IITs, as well as, the associated risks

    • Discuss suggestions for risk-based audit plans, sampling and testing techniques for IITs

    • Share success stories and lessons learned conducting IIT audits at a designated cancer center.

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The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

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About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

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