On 11 July, 2019, the FDA issued guidance for Institutional Review Boards (IRBs), industry, clinical investigators, and FDA Staff regarding live case presentations during Investigational Device Exemption (IDE) clinical trials. In its guidance, the FDA discusses human subjects protection measures, informed consent, additional considerations for children, and data collection and reporting issues associated with live case presentations.

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GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

This course is suitable for individuals proposing to conduct clinical trials of drugs, biologics, and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum. It covers key topics in clinical research including:

  • Reviewing FDA regulations
  • Identifying investigator and sponsor obligations
  • Discussing new drug development
  • Comparing International Council for Harmonisation (ICH) GCP E6 and FDA regulations
  • Describing how to detect and report adverse events
  • Auditing and monitoring expectations

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