On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how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) serves to enable research in the network entities.

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 of you have heard, several … Read more

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, webinars, an online community of … Read more

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 general questions: Cancer IDS: NConcologyIDS@unchealth.unc.edu … Read more

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 two IDS pharmacists have been … Read more

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 individual who may be responsible … Read more

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 – currently 620 SOM faculty and … Read more

Dear SOM Clinical Research Community, Please take a moment to review the information about the PaTS system in prior announcements and complete your profile at https://apps2.research.unc.edu/crso/. All SOM faculty and staff involved in the conduct of human subjects research are asked to complete a profile no later than July 30th. FAQs Q: If my research … Read more