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 This guidance takes the place of “A Guide to Informed Consent,” issued in September 1998, and finalizes the 2014 draft guidance titled, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.”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On June 6, 2023, The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled “E6(R3) Guideline for Good Clinical Practice.”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The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline.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
University of North Carolina at Chapel Hill Office of Sponsored Programs New Temporary Procurement Process of Gift Cards for Study Subject Incentives April 24, 2023 Beginning 4/24/2023, the Office of the Vice Chancellor for Research (OVCR) and the Office of Sponsored Programs (OSP) will offer a process to procure gift cards for study subject incentives when the … Read more
University of North Carolina at Chapel Hill Office of Sponsored Programs Prepaid Card Program Updates and Reminders April 14, 2023 As communicated in the March 13 Finance memo, the closure of the Bank of America (BoA) prepaid card program is forthcoming on June 30, 2023. Below are updates and reminders as you prepare for … Read more
The U.S. Food and Drug Administration (FDA) published a final guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.” The guidance provides sponsors with information about implementing a risk-based approach to monitoring clinical studies of human drugs, biologics, medical devices, and combinations of these products. As the recommendations are intended for sponsors, they apply directly to UNC investigators who initiate and conduct clinical investigations (that is, sponsor-investigators).
Collaboration is a key strength across the UNC School of Medicine for fostering connections and bolstering the translational research pipeline.
Expand your research network with the Faculty Collaboration Database!
REVISED 5/26/2023: Please contact OHRE directly by email about IRB education requests. Dear Research Community: You can now request an IRB Presentation with our Education Team Online. https://research.unc.edu/human-research-ethics/training-and-education-resources/ohre-irb-education-request-form or by going to https://research.unc.edu/human-research-ethics/ and click on Request a Training We look forward to hearing from you! Laura C. Munn, Office Manager
The CRSO, NC TraCS, and LCCC are pleased to announce a training opportunity for SOM faculty interested in becoming a site investigator for multicenter clinical trials. The Clinical Trialist Training Program provides 10% salary support for SOM faculty to participate in both didactic and experiential training and fosters the development of a clinical trial portfolio … Read more
Important notice regarding the closure of the BoA Prepaid card program as of 6/30/2023. Erika Hanami, CCRC Project Manager UNC Dermatology and Skin Cancer Center Chair, UNC Network for Research Professionals 410 Market St, Suite 400 Chapel Hill, NC 27516 984-974-3669 Erika_Hanami@med.unc.edu Join the NRP Listserv From: Office of Sponsored … Read more
Dear SOM Clinical Research Community, If you have the responsibilities of a Principal Investigator or Sponsor/Investigator, please be sure to login to PaTS to review the SOM SOP 301.1, Performing the Responsibilities of the Principal Investigator and complete your attestation no later than 5/2/2023. The CRSO will host two informational sessions to provide … Read more
All, The NIH is hosting a training class on the NIH Common Data Element Repository on March 29, 2023. From the NIH flyer: Do you want to standardize the data you collect so it can be easily shared with colleagues and other researchers? Have you been awarded a grant that requires the use of common … Read more
Self-assessment is a valuable activity that can improve the quality of clinical research operations and data. With the newest additions to the self-assessment toolbox, study teams can demonstrate due diligence in participant eligibility confirmation and study team qualifications and delegation documentation!
Dear SOM Clinical Research Community, The CRSO is excited to announce that SOM SOP 301.1, Performing the Responsibilities of the Principal Investigator, has been issued. The SOP will take effect on 4/3/2023 and applies to all human subjects research led by SOM investigators. If you have created your PaTS profile and indicated that you have … Read more
Dear Wonderful Research Community! Look what’s coming to a workstation near you……….. ISD has been working on a new project that will go live in a few weeks regarding how users access Epic. When you currently click the Epic@UNC icon, it utilizes what is called Hyperspace. Epic is trying to migrate a lot of … Read more
A competent and knowledgeable clinical research workforce is essential for the successful conduct of clinical research. Academic medical centers across the U.S. recognize this and are developing high-quality competency-based education and training materials for clinical research professionals. The DIAMOND portal brings these training materials to you!
Dear SOM Clinical Research Community, A primary objective of the SOM CRSO is to understand the needs of the clinical research workforce and develop resources, tools, and broad initiatives to support personnel and operations. One key source of information that enables us to understand experiences and perspectives of the clinical research workforce is responses … Read more
It can be challenging to navigate the Department of Health and Human Services (HHS) regulations for the protection of human subjects (“The Common Rule”) in a rapidly changing landscape of biomedical and health-related research. The UNC Chapel Hill required CITI Human Subjects Protection (HSP) Training and CITI HSP supplemental training modules provides a comprehensive review of HHS Common Rule requirements, but if you are looking for additional educational resources, the HHS Office of Human Research Protection (OHRP) offers educational materials to further human subjects protection.
Survey Request: Enhancing inclusion of Spanish-speaking participants in research Over the past decade, North Carolina’s Latino/a/x population has grown by 40%, the largest numeric increase of any racial/ethnic group in the state and faster than the growth of this population nationwide (23%). Despite this growth, Latino/a/x and other marginalized ethnic groups are vastly underrepresented … Read more
It can be challenging to decide if a project represents Quality Assurance (QA)/Quality Improvement (QI) or qualifies as Human Subjects Research (HSR). To mitigate this challenge, we have developed a QA/QI frequently asked questions document and a screening checklist.
Greetings Research Community, Epic@UNC Research is excited to announce a new, easier workflow for research coordinators to prep orders to be signed by Principal Investigators and Co-Investigators. Instead of providers having to hunt for a pended order inside an encounter, they will now receive an Epic Inbasket message. The orders will not be actionable until … Read more
As clinical researchers, a large part of what we do involves working together through collaboration, mentoring, and direct support. However, it can be challenging to identify the right person for a specific activity. The School of Medicine (SOM) CRAU Directory mitigates this challenge by enabling you to identify personnel with specific expertise and responsibilities across the entire SOM.