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Description
This webinar introduces the role of sponsor-investigator in a clinical trial and discusses regulatory and study management responsibilities. It also provides practical guidance regarding protocol design (including considerations for study monitoring and data management) and study conduct (including supervision and complying with reporting requirements). It reviews important considerations for clinical trials of drugs and devices. Further, the presenter explores how a sponsor-investigator may collaborate with internal organizational research staff and leverage external resources.
Learning Objectives
- Define the sponsor-investigator role.
- Identify sponsor-investigator regulatory responsibilities.
- Discuss considerations for study planning including: study design, leveraging resources, and working with research/institutional support services.
Audience
Clinical Research Coordinators, Institutional Officials, Principal Investigators, Research Staff, University Faculty & Post Docs
Meet the Presenter
Melissa A. Scotti, PhD, CIP – Northwell Health
Dr. Melissa A. Scotti received her PhD in Biology from Indiana University and after completing two postdoctoral fellowships transitioned to research compliance. Dr. Scotti’s experience includes positions with University of Colorado Health, Columbia University Medical Center, and Northwell Health. As a member of Northwell’s Office of Research Compliance she provides regulatory and QI/QA support to sponsor-investigators
