Dear SOM Clinical Research Community, Several upcoming changes to UNC guidelines and processes have been announced in the past weeks. To support ongoing understanding of and compliance with the current guidelines, the SOM CRSO has retired the previous “UNC SOM GUIDELINES FOR HUMAN SUBJECTS RESEARCH IN THE CONTEXT OF COVID-19” document and replaced it with … Read more

To:  Research Community,As we prepare for the June 1, 2021’s new research guidelines and moving towards normal operations with ongoing recommendations from the Office of the Vice Chancellor for Research, the OHRE is removing the requirement for the COVID Information Sheet.  Please note we have attached an IRB letter, approving the discontinuation to utilize for … Read more

UNC Clinical Research Community, In an effort to continuously improve process to maintain reliability and provide the most efficient path to study opening, UNC Investigational Drug Services (IDS) is working with UNC ISD Epic builders to streamline the process of requesting new build in Epic for study drug ordering. Currently, requests for new drug build … Read more

Dear SOM Clinical Research Community, In early March we administered a survey to assess job satisfaction among clinical research staff. We received 102 complete responses, including many valuable and insightful open-ended comments. The survey findings suggest that the highest levels of satisfaction relate to workplace recognition (e.g. opportunities to contribute to important human subjects research … Read more

The 21st Century Cures Act enables patients to easily and quickly access their own health records. At UNC, notes and results will be shared once finalized in Epic, but NOT research notes. Make sure you’re in the know!

The requirements for obtaining and documenting informed consent for research studies are defined by the FDA, DHHS, ICH GCP, and local IRBs. The requirements vary depending on the exact study characteristics. Knowing what applies and how to operationalize the required procedures for various studies can seem overwhelming, but there are some general best practices to keep in mind!

The UNC-Chapel Hill Office of Human Research Ethics (OHRE) is excited to announce a large enhancement in IRBIS is expected to go live the evening of May 6th, 2021.  This update is based on feedback from our research community and will allow for a personnel modification to be processed at the same time and be … Read more

NRP Did you Know? What are Data Security Contacts and Who Are They? The IT Data Security Contacts are individuals who have been identified by IT leadership in your school, center, or institute for your administering department. These individuals assist the PI with ensuring their research data are properly safeguarded. PIs and project coordinators are … Read more

Dear SOM Clinical Research Community, Please carefully review the announcement shared below from the UNC Office of Clinical Trials and UNC Health. **UPCOMING CHANGES TO BILLING COVERAGE ANALYSIS and CHARGE REVIEW PROCESSES** The Office of Clinical Trials and UNC Health announce upcoming changes to the billing coverage analysis and charge review processes effective April 11, … Read more

Dear SOM Clinical Research Community, Please see the below information disseminated today from Carolina Leadership: “While the University is not requiring the COVID-19 vaccine for students, faculty or staff, it is helpful to know the percentage of the community that is vaccinated. UNC Environment, Health and Safety has set up a website where employees can … Read more