News: 2024
Please see below for clinical research compliance news. The most recent news appears first.
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
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
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
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