Compliance
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January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices“.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