Please encourage all monitors to perform remote monitoring as much as possible, and to utilize onsite monitoring when only absolutely necessary. A REDCap survey has been developed to enable tracking and approval of requests for essential onsite monitors for University spaces.
Thank you to those who attended the WCG IRB Connexus Portal training! For anyone who was unable to join us or who would like to re-watch the training, this article contains a link to the recording of the training session.
A Virtual Visit is a “mode of delivery of healthcare services that is provided via telecommunications”. At UCHealth that means via videoconferencing such as the Vidyo application. A telephone call to a patient is not considered a virtual visit. At this point in time, all virtual appointments need to be scheduled by the clinic.
UCHealth RA has published an Ancillary Services - Certifications and Registrations resource page. This page will provide imaging specifications, UCHealth Radiology and Lab accreditations, and other frequently asked elements from study sponsors.
At UCHealth, we must do everything possible to ensure our patients’ safety – as well as our own. As we continue to fight the spread of COVID-19, it is even more critical this year that we act early against the flu to protect our patients, staff and providers.
On Tuesday, September 15, 12:00 p.m.-1:00 p.m. ET (10:00 a.m.-12:00 p.m. MT), the U.S. Food and Drug Administration (FDA) will host a webinar to review these topics:
1) Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency
2) Umbrella Emergency Use Authorization (EUA) for Gowns and Other Apparel
As part of continuing efforts to improve efficiency, the CRAO contracts group will begin assigning CTAs and CTA amendments for review based on a rotation rather than according to department as we have done to this point. We are adding additional reviewers into the rotation for CDAs and MTAs as well.
There is a new question in the amendment portal that submitters will see that asks, is this an internal amendment. This question is reserved for UCHealth Research Administration. All study team amendment portal submissions should answer NO to this question.
In order to leverage the benefits of the UCHealth system and promote the highest level of care for our patients, the Senior Quality Group has established the Registries Steer Committee to oversee the allocation of resources surrounding research registries utilizing clinical registries. Moving forward, the committee will review requests for registries to assess the registry benefit across the system.
University Research is launching a new clinical research forum that will happen once a month via Zoom. Please take part to learn about the different resources available for you regarding your specific work.
The UCHealth influenza vaccine campaign is on schedule to launch system-wide on Wednesday, September 8, 2021 for all patients. Employee Health immunization campaigns will begin the week before on Wednesday, September 1, 2021. All research staff entering UCHealth facilities will be required to be vaccinated prior to the November 12, 2021 deadline.
Clinical research monitors and auditors who must be physically present in UCHealth facilities are required to establish and maintain a SEC³URE Ethos account with UCHealth’s vendor credentialing service, IntelliCentrics (formerly RepTrax).