Author Archives: Catherine Barnes

On October 1, 2021 the UNC-Chapel Hill OHRE released the newest version of SOP 1401 – Promptly Reportable Information. This replaces SOP 1401 – New Safety Information and is in effect as of October 1, 2021. This revision was done to align definitions across collaborating institutions, comply with FDA requirements...

On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how investigators must assess and report adverse events to ensure participant safety in drug and device studies.

The UNC Health Care System (UNCHCS) includes hospitals across the state that serve the people of North Carolina. Conducting research activities at locations outside of the UNC Chapel Hill Medical Center can broaden the impact and diversity of your study data. The UNCHCS Office of Research Support and Compliance (ORSC)...

Dear All, Please see below information from Tess Cummings, Director for the UNC Lineberger Clinical Protocol Office. Tess has done an outstanding job in pulling the SIP process and requirements together, her tireless efforts are much appreciated. Many thanks, Christine Nelson   ********************************************************************************************************************** Good Morning UNC Research Community, As many...

Dear SOM Clinical Research Community, As part of our mission to promote continuous professional development and a culture of quality across the SOM, the CRSO and NC TraCS are partnering to offer 5 individual year-long ACRP memberships to SOM clinical research staff. ACRP membership offers access to vast e-learning courses,...

Hi everyone, Please keep an eye out for updated Epic Details Bills for your research studies that include the research pricing. Thanks for patience while this issue was resolved. Thanks! Epic@UNC Research Team EpicUncResearch@unchealth.unc.edu

Dear SOM Clinical Research Community, As a reminder, Andy Thorne, previous Clinical Manager of the UNCH Investigational Drug Pharmacy (IDS), is no longer at UNC. Please make note of new contact information for IDS.   IDS pharmacy leads: Cancer IDS: Sharon Guerry (Sharon.Guerry@unchealth.unc.edu) General IDS: Maria Bullis (Maria.Bullis@unchealth.unc.edu)   For...

Research community at UNC, I will be departing UNC Health after this week. I am proud to have worked with so many of you on meaningful research that is helping to shape the future of medicine and positively impacting the lives of our patients. I am happy to share that...

Dear SOM Clinical Research Community,   The SOM CRSO is in the process of developing a portfolio of Standard Operating Procedures (SOPs) widely applicable to clinical research conducted across the SOM to achieve efficient and consistent workflows, ensure regulatory compliance, and realize best operational practices in clinical research.  As an...

Dear SOM Clinical Research Community, If you have not yet completed your personnel profile in the new SOM Personnel Profile and Training System (PaTS), please take a few minutes to do so by the end of this week: https://crso.unc.edu/pats Thank you to all who have already completed a profile –...