The IBC reviews
human clinical trials involving Human Gene Transfer, Live Vaccine, and some institutionally-mandated investigational compounds. The IBC also reviews manufacturing activities on CU-affiliated institutions that pertain to biological substances, such as potential clinical compounds. Clinical trials and manufacturing protocols ARE NOT processed in Cayuse. These trials are processed via email submission packages only.
The CU Denver | Anschutz IBC requires a clinical trial submission package including all required documents prior to review consideration at the next IBC meeting. Review the Guidance File for IBC reviewed clinical trials prior to submitting an application. The IBC Clinical Trial Application should be completed as part of the application package. The Biosafety Site-Specific SOP is required for the application package as well.