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.
Webinar Title: “Importance of Increasing Diversity in Clinical Trials- Minority and Underserved Communities: Recruitment & People of Sub-Saharan African Descent.”
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).
REMINDER: If your industry sponsored/supported clinical study will utilize the services of a third party home health provider, your contract reviewer needs to know!
To keep our patients and their families safe from influenza (the flu), annual flu shots are required for all UCHealth employees, medical staff, volunteers, students, vendors and contractors who come into our facilities. Importantly, this requirement includes all research staff who enter UCHealth facilities.
OnCore TRAIN will be getting upgraded on Monday, August 23rd and will be unavailable the entire week. We anticipate having it available for users on Monday, August 30th.
Effective immediately, for UCD, DHHA, UCHealth and CU Medicine Clinic Protocols, the following human subjects research projects must now be submitted through the HSR Portal: exempt studies with outside funding, studies that are minimal risk (expedited review), and studies that are more than minimal risk (full board).
The Food and Drug Administration (FDA) has issued the final guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The guidance is intended for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.
Annual flu shots are required for all employees, medical staff, volunteers, students, vendors and contractors who come into our facilities. This includes all research staff who enter UCHealth facilities. In September, UCHealth Employee Health and Well-being will begin administering mandatory flu vaccinations for staff.
At the direction of UCHealth leadership, all UCHealth employees will take 64 hours of PTO between 7/1 and 8/31. As a result, all members of UCHealth research administration will have varying days off during this time period.
Federal and IIT sponsored studies that utilize telehealth services instead of in person physical exams will be subject to payment based on the date of service.
Due to the COVID-19 outbreak, the Research Compliance Office at Children’s Colorado has created virtual sessions so we can engage and connect with each other while we’re social distancing.
When adding services in the Amendment Portal, study teams are taken to the Ancillary Services survey in the Amendment Portal if they answer "Yes" to the following question: "Will there be NEW CHCO ancillary services attached to this protocol?"