Dear SOM Clinical Research Community,
In an increasingly complex regulatory environment, it can be difficult to stay on top of and to navigate all the federal, state, and institutional regulatory news and trends in clinical research. To address this challenge, the CRSO has added a new regulatory blog to their website that will deliver timely, concise, and engaging reviews of key trends and regulatory developments. Click here to bookmark the new blog and review our featured regulatory posts.
Our first new post is on the modernization of the ICH E8 guidelines, General Considerations for Clinical Studies, adopted and issued by the U.S. Food and Drug Administration (FDA) on April 8, 2022. The E8(R1) revision, the first major revision since 1997, provides a shift towards greater efficiency and a focus on quality by design. It 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).
If you have any regulatory updates or other applicable content you would like us to write about, please email the CRSO at CRSO@unc.edu.