The CRSO is excited to announce that the following new and revised SOPs will be issued today for the SOM clinical research community and posted in the Clinical Research Profile and Training System (PaTS). The SOPs will take effect on December 14, 2023. New SOPs: SOM SOP 201.1: Developing and Maintaining Clinical Research Standard Operating … Read more

The U.S. Food and Drug Administration (FDA) announced in August that it has finalized the guidance document titled “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” to promote clarity on procedures and expectations for stakeholders carrying out informed consent in clinical investigations of FDA-regulated products. This guidance takes the place of “A Guide to Informed Consent,” issued in September 1998, and finalizes the 2014 draft guidance titled, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.” The informed consent guidance does not address future potential changes to FDA’s informed consent regulations that may result from the FDA’s harmonization efforts with the 2018 Common Rule.

On June 6, 2023, The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled “E6(R3) Guideline for Good Clinical Practice.” This E6(R3) update aims to provide flexible, modern, and clear Good Clinical Practice (GCP) for conducting clinical research.
The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline. As a founding member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry.

The CRSO has created a bridge webpage to optimize access to clinical research-related policies and procedures housed in the SOM, UNC-Chapel Hill Electronic Policy Repository, and UNC Health PolicyStat.
Explore the CRSO’s Policies and Procedures bride page to access and review UNC Chapel Hill and UNC Health clinical research-related policies and procedures.

University of North Carolina at Chapel Hill Office of Sponsored Programs Prepaid Card Program Updates and Reminders May 31, 2023 As a reminder, the closure of the Bank of America (BoA) prepaid card program is forthcoming on June 30, 2023. Below are reminders to prepare for the transition. Please also see the April 14 Finance memo … Read more

Dear SOM Clinical Research Community,   Clinical research staff are essential to the successful conduct of clinical research studies and trials. We recognize that a strong and sustainable clinical research workforce is key to ensuring the quality and productivity of the clinical research enterprise of the UNC SOM, ultimately developing knowledge that will improve the … Read more

Building on recommendations to facilitate decentralization of clinical trials during the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA or the Agency) issued the draft guidance titled, Decentralized Clinical Trials for Drugs, Biological Products, and Devices on May 2, 2023. A decentralized clinical trial (DCT) is a clinical trial where some or all trial-related activities occur at locations other than traditional clinical research sites.

Dear SOM Clinical Research Community, The UNC Health Office of Research Support and Compliance (ORSC) has a new SharePoint site! On the new site, you can review information about all of the UNC Health network partners, initiate a request to conduct research in collaboration with a network site, review policies and procedures for research conducted … Read more

Dear SOM Clinical Research Community, As you are likely aware, the Bank of America prepaid card program that has been utilized for providing payments to research participants is being terminated. The Office of the Vice Chancellor for Research (OVCR), the Office of Sponsored Programs (OSP), and UNC-Chapel Hill Accounting Services have been partnering to identify … Read more

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