Regulatory Blog

Central administrative office supporting all human subjects research across the SOM

Please see below for key trends and regulatory developments in clinical research. The most recent announcements appear first.

On April 8, 2022, the U.S. Food and Drug Administration (FDA) adopted and issued the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1) General Considerations for Clinical Studies. ICH E8 guidelines sets out general scientific principles for the conduct, performance, and control of clinical trials, and addresses a wide range of topics in trial design and execution. This revision is the first major revision since 1997 and marks the initial step in the ICH’s Good Clinical Practice Renovation project and will continue with the revision of E6(R2) guidelines on Good Clinical Practice (GCP).

On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how investigators must assess and report adverse events to ensure participant safety in drug and device studies.

FDA Issues ICH E8 Revision

FDA Draft Investigator Responsibilities Guidance