Skip to main content

Important Update: SOM Guidelines for Human Subjects Research

January 4, 2021

Dear SOM Clinical Research Community, In planning for spring semester, UNC HR recently disseminated new resources and policies to support students and employees navigating changes associated with COVID-19. UNC employees whose work requires them to report to campus are now required to complete a daily wellness assessment at ehs.cloudapps.unc.edu/UEOHC/covid19wellness. Utilization of this new web portal … Read more

FDA-Regulated Research

October 21, 2020

Research studies that are considered FDA-regulated are required to comply with specific FDA rules and regulations. It is imperative that the PI and study team understand what applies and how to maintain compliance. Is your research FDA-regulated?

Clinical Research or Clinical Practice

August 25, 2020

Many research participants are also patients undergoing clinical care. Many study investigators are also clinicians providing clinical care. When is it important to clearly delineate between clinical research and clinical care? Always!

Data Security Considerations

July 18, 2020

With increased needs for technology solutions and electronic tools for conducting clinical research, it is important to recognize who has responsibility for determining if those tools are appropriate for clinical research use. Hint, it’s not the IRB.