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 

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.