Compliance News
New Research Policy Category Organization Now Live in the UNC Policy Repository
June 30, 2025
Dear Colleagues, We’re pleased to share that the UNC Policy Repository has been updated with a new,more intuitive research policy category structure. This change is designed to improvenavigation and help
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
Research Science and Security Launches Wave 1 of the Research Security Training
April 17, 2025
The Research Science and Security office is launching the University of North Carolina’s research security (RS) training program. This training is being released in two waves, in order to pilot
Visa Sponsorship Review Request form has moved into RASR
April 16, 2025
| April 16, 2025–We are pleased to announce that the we have simplified the intake form for the visa sponsorship reviews requests and moved the form into RASR. The new
Planned launch of UNC-Chapel Hill’s new research security training program
April 8, 2025
This message is from Brian Collier, director of science and security in the Office of the Vice Chancellor for Research. In July 2024, the federal government, via the Office of
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January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products,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
Expansion of Self-Assessment Series to Promote Clinical Research Quality and Compliance
December 13, 2024
December 16, 2024—The Clinical Research Compliance Office (CRCO) is pleased to announce the expansion of the Self-assessment Series originally developed by the School of Medicine’s Clinical Research Support Office (SOM
New Policy on the Use of Electronic Signatures for Essential Documents in Clinical Research
December 12, 2024
December 12, 2024—The Clinical Research Compliance Office is pleased to announce the University of North Carolina at Chapel Hill Policy on the Use of Electronic Signatures for Essential Documents in
University of North Carolina at Chapel Hill Position Statement on Part 11 Compliant Regulatory System
December 9, 2024
December 9, 2024—The UNC-Chapel Hill has released a position statement on December 9, 2024, regarding the implementation of a Part 11 compliant regulatory system for clinical trials. This statement highlights