CRCO News
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January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices“.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
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 CRSO). This initiative aims to enhance the quality and compliance of clinical research. The CRCO Clinical Trials Quality Assurance team (CTQA) has added a new ... Read more
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 Clinical Research. This policy aims to ensure regulatory compliance, enhance efficiency, and improve oversight of electronic signatures. Purpose: The policy establishes the requirements for using University-approved ... Read more
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 the university’s commitment to regulatory compliance and data integrity. Summary: The University of North Carolina at Chapel Hill utilizes Veeva SiteVault, ensuring compliance with FDA’s ... Read more
New Process for Requesting IND/IDE Support Services
December 6, 2024
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 should be submitted through the REDCap survey form, which can be accessed via the following ... Read more
New Resource: Guide to Sponsor-Investigator Management of Multisite Studies
September 20, 2024
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. This guide is designed to assist Principal Investigators in navigating each phase of their study ... Read more
New Resources for Investigator Record Retention and Disposition
September 18, 2024
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 investigator records, including definitions, retention periods, and specific requirements for different types of research. It ... Read more