Effective May 7th, the UCHealth Research Administration website will transition to the Cloud. If you need access to this new site – you will need to contact 720-848-4000 to request a new invite to the new UCHealth intranet, The Source.
Effective April 1, 2021, the Office of Regulatory Compliance will launch a new data sharing request portal for intake of data sharing requests. This will replace the paper based request form and email intake process.
This access will soon be required to view information and updates related to changes that affect you and your role at UCHealth. Examples include obtaining research pricing, orientation steps for new researchers, COVID-19 updates, flu vaccinations, OnCore/Epic training, EHR monitor requests, and more.
To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER launched a new webpage to disclose information from their scientific review documents supporting Emergency Use Authorizations (EUA) for drug and biological therapeutic products.
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.