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
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.
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.