Compliance News

Update on LMS Completion Data and Carolina Talent

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 … Read more

Research Science and Security Launches Wave 1 of the Research Security Training

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 the training and incorporate campus feedback.  Additional Details: Who needs … Read more

Visa Sponsorship Review Request form has moved into RASR

| 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 form is accessible on the International Student and Scholar Services … Read more

Planned launch of UNC-Chapel Hill’s new research security training program

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 Science and Technology Policy, released their guidelines for research security … Read more

New FDA Draft Guidelines on Protocol Deviations

January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices“.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

New ICH E6(R3) Guideline for Good Clinical Practice

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 … Read more

Expansion of Self-Assessment Series to Promote Clinical Research Quality and Compliance

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 CRSO). This initiative aims to enhance the quality and compliance … Read more

New Policy on the Use of Electronic Signatures for Essential Documents in Clinical Research

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 Clinical Research. This policy aims to ensure regulatory compliance, enhance … Read more

University of North Carolina at Chapel Hill Position Statement on Part 11 Compliant Regulatory System

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 the university’s commitment to regulatory compliance and data integrity. Summary: … Read more

New Process for Requesting IND/IDE Support Services

December 6, 2024—We are excited to announce a new streamlined process for submitting requests for Investigational New Drug (IND) and Investigational Device Exemption (IDE) support from the Clinical Research Compliance Office. Starting January 6, 2024, all requests for IND/IDE support … Read more

New Resource: Guide to Sponsor-Investigator Management of Multisite Studies

September 20, 2024—We are excited to announce the release of the Guide to Sponsor-Investigator Management of Multisite Studies! Successfully managing a multicenter study under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application demands meticulous planning and execution. … Read more

New Resources for Investigator Record Retention and Disposition

September 18, 2024—We are pleased to announce the release of two new resources designed to assist investigators with the retention and disposition of clinical research investigator records: Investigator Records: Retention and Disposition FAQs: This FAQ document addresses common questions about … Read more