Studies requesting credentialed UCHealth clinical care providers (who are not listed as study personnel) to administer study medications require an oversight plan addressing the phase of the study, experience of the investigator, patient population, known risk of the study medication, and how oversight will be provided and documented, in accordance with FDA regulations.
Join Research Compliance at Children’s Colorado on Fridays at 10:00 AM on Zoom. Topics range from week to week, from handling PHI remotely and virtually to discussing alternative ideas for obtaining research informed consent.
The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about prevention, vaccines, clinical trials, and vaccine side effects.
Study teams who wish to use eREG for their studies will be charged a one time fee of $1000/per study. The Institution is obligated to charge F&A on this fee. Please be sure to account for it in your budget.
In UCHealth’s instance of Epic, SlicerDicer is not an appropriate tool for research end users. Access to this tool is not part of the research templates. If you have reporting needs for your study or recruitment, please reach out to UCH-ResearchAdmin@uchealth.org or submit a report request through HealthDataCompass.
Questions have been raised by several clinical trial sponsors requesting additional information and reassurance that clinical research on the Anschutz campus was not impacted. In response, the following memo has been drafted. It is recommended that you keep a copy of this memo in you clinical trial research binder and provide to the sponsor if they contact you for information.
The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about vaccines, side effects, and the Vaccine Adverse Event Reporting System.
Starting May 5th, the CTRC will resume conducting in-person sessions of CTSA3. To ensure safety, we have made a few changes. Please note the following information before registering or attending a session.
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.