CRCO News
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 compliant delegation of clinical tasks in human subjects research. Purpose: The policy outlines the requirements for delegation of clinical tasks to personnel in the conduct ... Read more
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 data capture, and risk-based oversight. UNC’s Approach UNC will integrate these updates into our existing training process without requiringadditional or early training for staff. Next ... Read more
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 employees and supervisors to include their UNC Health training commitments as a component of our job performance.
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January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices“. This guidance, issued in December 2024, provides comprehensive recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and ... Read more
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 (ICH) website on January 6, 2025. This step indicates their readiness for adoption by regulatory authorities. The E6(R3) Guideline seeks to build on the themes ... Read more