Most research teams are aware of the requirements to list clinical trials and upload results to clinicaltrials.gov, but did you know you are also required to post the consent form? The 2018 Requirements state that a consent form must be posted to a designated federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.
Self-assessment is a valuable activity that can be informative in a variety of settings, including informed consent for clinical research. Now you can proactively discover your informed consent process strengths and areas for improvement using a new Informed Consent Self-Assessment tool!
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued