Sponsor Responsibilities

This presentation will provide an overview of the sponsor responsibilities for conducting clinical research. The presentation will address sponsor responsibilities for regulatory submissions, site selection, documentation, and monitoring. Safety and regulatory reporting will also be discussed. As clinical trials expand throughout the globe, it is important to understand the regulatory and ethical responsibilities of the Sponsor. 


LEARNING OBJECTIVES: 

Describe sponsor responsibilities for conducting clinical research

Discuss responsibilities for regulatory submissions, site selection, documentation and monitoring

Discuss safety and regulatory reporting 


Amy Jo Jenkins, MS, CCRP

Director, Clinical Trials Office

University of Arkansas for Medicial Sciences, Winthrop P. Rockefeller Cancer Institute

Amy Jo Jenkins has 20+ years of experience working in clinical research and currently serves as the Director of the Clinical Trials Office at the Winthrop P. Rockefeller Cancer Institute, where she also teaches courses in the Regulatory Science Program at the University of Arkansas for Medicial Sciences. She earned her Masters of Science degree in Clinical Research Organization and Management from Drexel University and Bachelors of Science degree in Molecular Biology from Grove City College.  She has been a Certified Clinical Research Professional since 2010 and has served on the SOCRA Board of Directors since 2016.

DISCLOSURE OF RELATIONSHIPS AND DECLARATIONS: CNE AND CME ACCREDITED SOCRA PROGRAMS

SOCRA adheres to the ACCME’s & ANCC’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

SOCRA program content addresses regulatory issues and clinical research policies and procedures, no commercial therapies are discussed, no commercial (drug/device/biologic) products are discussed, and no commercial support is involved with SOCRA programs.

Planners and Speakers for programs have no undisclosed commercial relationships.

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