How do I submit my Investigator’s Brochure (IB) update to the IRB? Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)? It depends… IBs are reviewed annually and may be updated with Investigational Product (IP) information which does … Read more

Whether you are new to clinical research or an experienced member of the research team, mastering the highly specialized vocabulary (and alphabet soup!) of clinical research and using it effectively in professional communications can be challenging. To bolster understanding and facilitate effective communication in the SOM and beyond, we have created a concise and organized glossary of clinical research terms that aligns with industry and regulatory standards.

Update regarding the shortage of contrast media from Lauren M.B. Burke, MD, FSAR, executive Vice Chair of Radiology In the last few weeks, GE has increased production of Omnipaque 300 and 350, the most common contrast media concentrations used in Imaging Services, with production currently at or above 75% of typical production.  UNC has been … Read more

  THE UNIVERSITY of NORTH CAROLINA at CHAPEL HILL Office of Sponsored Research – Communication   Pre-Paid Card Updates New Resources, Updated Forms, and Year-End Deadlines Release Date: June 9, 2022 The Office of Sponsored Research (OSR) in conjunction with the Finance Cash Management Team has created new resources and updated forms for PrePaid Cards. Guidance … Read more

The CRSO recently published the UNC Research Contacts webpage on our website. This webpage includes contact information for various UNC-CH research offices and services.

Updated message from the UNCH Health Information Management and Epic Research teams: Good morning Research Community! After a little hiccup yesterday, we’re happy to announce that the MySupport Research Monitor Visit Request process is officially LIVE. We’ve updated one element of the tip sheet, Please delete the tip sheet sent on 5/27/22. Additionally, we’ve updated … Read more

Dear SOM Clinical Research Community, Thank you for your engagement, feedback and questions related to the new personnel Profile and Training System (PaTS) and SOM-wide Standard Operating Procedures (SOPs)! Please review the FAQs listed below. We will continue to add additional information to the CRSO website as we work to make new tools and processes … Read more

A Message from the UNCH Health Information Management and Epic Research teams: Greetings Research Community, We are excited to bring to you, much needed process enhancements with how you request Epic access for research monitoring visits. In anticipation of HIM operations processing ALL monitoring request for Epic access, UNCH HIM and Epic@UNC Research teams collaborated … Read more

Dear SOM Clinical Research Community, If you are involved in obtaining informed consent from adult research participants, please be sure to login to PaTS to review the SOM SOP 401.1 and complete your attestation no later than 6/14/2022. The CRSO will host two informational sessions to provide a general overview of the SOP, answer questions, … Read more

Dear SOM Clinical Research Community, In early March we distributed a survey to assess job satisfaction among clinical research staff. We received 116 responses; 76% from staff with 5 or more years of clinical research experience. Overall, 66% of respondents indicated that they are either somewhat satisfied or very satisfied in their jobs. The most … Read more