eReg Resources

Getting Started 

  1. Study Staff Startup Checklist for eReg
  2. Study Regulatory Binder Startup Checklist for eReg
  3. UCSF eReg Guidance

Watch the recording of Introducing UCSF's Advarra eReg Regulatory Binder System (March 2026)

Quick Guides

  1. Import a Protocol and Staff
  2. Edit Protocol Outline
  3. Resetting Your Pin
  4. Document Integration (Email, OnCore, & Advarra IRB)
  5. Delegation of Authority
  6. Add Subjects to a Protocol
  7. Create a Review Session
  8. Manage Investigational New Drug (IND) Documentation (Requires Regulatory Manager Role)
  9. Standard Operations Procedures (Requires Regulatory Manager Role)
  10. Multisite - Coordinating Center (Requires Multi-Site Access Role)
  11. Multisite - Participating Site (Requires Multi-Site Access Role)

Top

Part 11 Compliance

Advarra eReg is validated as Part 11 compliant for FDA-regulated research at UCSF. UCSF has a non-repudiation letter on file with the FDA and a Part 11 Compliance Statement. Theses may be provided to sponsors if requested.

Part 11 Compliance Statement

UCSF's Non-Repudiation Letter

More Information on Part 11 Compliance at UCSF

Top

Questions?

eReg Support: [email protected]

eReg Office Hours (2nd & 4th Thursdays, 10:10-11am thru May)