The University of Colorado Anschutz Medical Campus (CU-Anschutz), University of Colorado Health system (UCHealth) and the Children’s Hospital Colorado (CHCO) use OnCore as a campus-wide platform to manage clinical research and facilitate fiscal and operational compliance. No research can be conducted in any facility without the proper approvals from the individual hospital and OnCore. All projects that are expedited or full board require OTA prior to enrolling participants.
As a result of recent changes, we are able to ramp up clinical research for review and scheduling of research visits for Groups 1-5. This change is effective February 19, but only for studies who have already been approved to resume research activity.
Occasionally, changes must be made to the HSR portal survey. If the “start over” button is selected when making changes, it will remove all responses from the form. Please use this option only when you need to delete every entry from your portal survey.
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
MyHealthConnection (MHC) is a secure patient message portal in Epic. With Research Administration, UCHealth Digital Patient Experience, and IRB approval, research recruitment messages may be sent in MHC. For participants already enrolled in a research study, MHC can be used to send IRB approved research related materials.
Clinical research will now return to previous COVID Orange restrictions: review and scheduling of research visits for Groups 1-4 and 5b. This change is effective Monday, January 25, for studies that have already been approved to resume research activity through the CU Anschutz Medical Campus research restart portal or the UCHealth restart process.
We now have the ability to add interpreters on-demand to virtual visits through a vendor, Stratus Video, for more than 150 different languages by audio or video. This will greatly expand access to care for many patients with Limited English Proficiency. This capability is live now, and the Virtual Health Team has provided guidance through tip sheets.
The FDA will be holding a public meeting to gather input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development. The meeting will be held on 2/2/21 from 10am-2pm and 2/3/21 from 10am-1pm.