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January 27, 2025 — We are pleased to inform you about the recent release of the FDA’s draft guidance document titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, … Read more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