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New and Revised SOPs Issued

November 14, 2023
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...

Insightalyst: FDA Informed Consent Guidance

September 1, 2023
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...

Insightalyst: FDA Draft Guidance — ICH E6(R3)

July 17, 2023
On June 6, 2023, The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled “E6(R3) Guideline for Good Clinical Practice.”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 The draft guidance is adopted from the...

Resource Hub: CRSO Policies and Procedures Bridge Webpage

June 28, 2023
The CRSO has created a bridge webpage to optimize access to clinical research-related policies and procedures housed in the SOM, -Chapel Hill Electronic Policy Repository, and Health PolicyStat. Explore the CRSO’s Policies and Procedures bride page to access and review Chapel Hill and Health clinical research-related policies...

Prepaid Card Program Updates and Reminders (NRP)

May 31, 2023
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...

SOM Clinical Research Staff Career Development Initiative

May 30, 2023
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 SOM, ultimately developing...

Insightalyst: FDA Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices

May 17, 2023
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...

Information for Research with Health Network Partner Sites

May 3, 2023
Dear SOM Clinical Research Community, The 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 Health network partners, initiate a request to conduct research in collaboration with a network site, review policies...

Changes to Payment Options for Research Participants

April 25, 2023
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 -Chapel Hill Accounting Services...

Tango Card Pre-Recorded Demo; Request for Feedback by Thursday, April 27, 2023 (NRP)

April 24, 2023
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