What you need to know
UCSF’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.
Key Benefits
- 21 CFR Part 11 Compliant
- Integration with UCSF’s OnCore Clinical Trial Management System
- Integration with Advarra CIRBI (for studies using this external IRB)
- Centrally managed solution at UCSF
What you need to do
- eReg Access and Training
- Review the eReg Roles
- Complete Required Role-Based Training
- Plan for 20min-2hrs of training via self-paced Courses in the UC Learning Center
- Submit the Account Request survey
- Check out eReg Resources for information on Getting Started, Quick Guides, Part 11 Compliance
- Reference the Study Staff Startup Checklist for eReg to help ensure your team has access and is ready to use eReg
- Use the Study Regulatory Binder Startup Checklist for eReg to get your protocols set-up in the eReg system
- Begin to use Advarra eReg for your studies!
Helpful Resources
- Join eReg Office Hours (2nd & 4th Thursdays, 10:10-11am thru May)
- Next session: March 26th
- Zoom: https://ucsf.zoom.us/j/94359483313?pwd=YF0qiMfoFuK4u9weTj2vB4A9WnJuzU.1
- eReg Access and Training
- eReg Resources
Questions? Contact eReg Support: [email protected]