The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted revisions to their Guideline for Good Clinical Practice (GCP) on January 6, 2025; the newly adopted version (R3) is available on the ICH website. Note that the final version of these revisions have not yet been adopted as guidance by the Food & Drug Administration (FDA) and the timing of such adoption is currently unknown. For additional information on these updates:
- Advarra and the Collaborative Institutional Training Initiative (CITI) have published summaries on their respective blogs.
- The WIRB-Copernicus Group (WCG) recently hosted a webinar highlighting key updates, the recording of which is available on their website.
- The Association of Clinical Research Professionals (ACRP) will host a webinar to review key components of the revised guidance document on February 13.
- Transcelerate BioPharma, Inc. will host a webinar to discuss tools and resources available for understanding and implementing revisions on March 4.
For additional information on GCP generally (e.g., what GCP is and how it applies to research), see OHSP’s GCP FAQ website.