It's easy to recognize that a study is regulated by the U.S. Food and Drug Administration (FDA) when working on an industry-sponsored protocol under Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Even then, however, clinical research professionals face challenges with documentation, sponsor communications, and institutional review board (IRB) requirements, especially when investigator-initiated or multisite studies complicate regulatory matters. We will walk through key indicators of IND/IDE applicability, common misconceptions, and decision points that affect regulatory classification and IRB review. We’ll also explore emerging trends in regulation of artificial intelligence/machine learning-based products, companion diagnostics, radiation-emitting devices, and digital health technologies, so that participants will leave with practical decision tools, case-based examples, and communication tips to support confident and compliant conduct of FDA-regulated research.

CEU: 1.00 ACRP

Speaker:

• Purna Garimella, MS, CIP, RAC, Director, Human Research Protection Program, Indiana University