Clinical Research Compliance News
Please see below for clinical research compliance news. The most recent news appears first.
New CITI Course Available –Â ICHÂ GCPÂ E6(R3):Â An IntroductionÂ
December 5, 2025
The International Council for Harmonisation (ICH) released the revised Good Clinical Practice guideline, ICH GCP E6(R3), in January 2025. The FDA subsequently adopted and issued guidance to industry in September 2025. These revisions modernize clinical research practices by
New Policy On Delegating Clinical Research Tasks In Research
September 18, 2025
The Clinical Research Compliance Office is pleased to announce the University of North Carolina at Chapel Hill Policy on Delegating Clinical Research Tasks in Research. This policy supports safe and
UNC Approach to ICH E6(R3) GOOD CLINICAL PRACTICE (GCP) TRAINING
August 28, 2025
The International Council for Harmonisation (ICH) released the revised Good Clinical Practice guideline ICH E6(R3) in January 2025. These revisions reflect current approaches to clinical research, including decentralized models, electronic
Update on LMS Completion Data and Carolina Talent
April 17, 2025
April 17, 2025 — We are pleased to share that certain UNC Health LMS training completions now port into Carolina Talent on a monthly basis. This functionality should better equip
New FDA Draft Guidelines on Protocol Deviations
January 27, 2025
January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products,
New ICH E6(R3) Guideline for Good Clinical Practice
January 22, 2025
January 22, 2025 — The ICH E6(R3) Principles and Annex 1 have been finalized and published on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use