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This is a reminder, if there have been changes to your study or you have noticed an error or omission on a BCA previously completed please reach out to the BCA team at resbilling@unc.edu Please include the CRMS and IRB numbers in your email.

On October 1, 2021 the ºÚÁÏÍø-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On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how investigators must assess and report adverse events to ensure participant safety in drug and device studies.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 ºÚÁÏÍø Health Care System (ºÚÁÏÍøHCS) includes hospitals across the state that serve the people of North Carolina. Conducting research activities at locations outside of the ºÚÁÏÍø Chapel Hill Medical Center can broaden the impact and diversity of your study data. The ºÚÁÏÍøHCS Office of Research Support and Compliance (ORSC)...

Dear All, Please see below information from Tess Cummings, Director for the ºÚÁÏÍø 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 ºÚÁÏÍø 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@ºÚÁÏÍø Research Team EpicUncResearch@unchealth.unc.edu

Dear SOM Clinical Research Community, As a reminder, Andy Thorne, previous Clinical Manager of the ºÚÁÏÍøH Investigational Drug Pharmacy (IDS), is no longer at ºÚÁÏÍø. 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 ºÚÁÏÍø, I will be departing ºÚÁÏÍø 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...