Getting Started
- Study Staff Startup Checklist for eReg
- Study Regulatory Binder Startup Checklist for eReg
- UCSF eReg Guidance (coming soon)
Quick Guides
- Import a Protocol and Staff
- Edit Protocol Outline
- Resetting Your Pin
- Document Integration (Email, OnCore, & Advarra IRB)
- Delegation of Authority
- Add Subjects to a Protocol
- Create a Review Session
- Manage Investigational New Drug (IND) Documentation (Requires Regulatory Manager Role)
- Standard Operations Procedures (Requires Regulatory Manager Role)
- Multisite - Coordinating Center (Requires Multi-Site Access Role)
- Multisite - Participating Site (Requires Multi-Site Access Role)
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 (coming soon). Theses may be provided to sponsors if requested.
Part 11 Compliance Statement (coming soon)