Coming soon from OCTA:New guidance for study teams on submitting Emergency Access Programs (EAPs) to the Office of Clinical Trial Activation, and how to manage them in OnCore and APeX. Stay tuned for additional detail which will be available on our website!
What you need to knowUCSF’s Advarra eReg tool is a 21 CFR Part 11 compliant electronic regulatory binder that includes participant source documents and supports efficient, compliant clinical research regulatory documentation.
On Behalf of the Office of Clinical Trial Activation (OCTA), Clinical Trials Operations (CTO), and Academic Research Services (ARS), we’re pleased to announce the upcoming launch of Advarra’s eRegulatory Binder System.