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.
To facilitate pharmacy review, UCHealth has added the following question to the PAF when UCHealth IDS services are requested. “Is this a platform trial?” Please answer appropriately.
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.