In this interactive session, experts will explore the various types of noninterventional minimal risk studies (including postapproval noninterventional studies, registries, safety-surveillance, and REMS) and their design to ensure compliance with regulatory requirements. The session will also explore the IRB, industry, and site perspective including the value of noninterventional minimal risk studies and models for streamlining the IRB review process.

Learning Objectives:
Describe the agency, IRB, industry, and site perspective regarding studies that qualify as non-interventional minimal risk research
Discuss the various types of noninterventional minimal risk studies.