Data Resources
Security & Storage
- Electronic Data Security
- Data Storage/Retention
- De-identification and Confidentiality of Research Data
Agreements & Governance
- Data Use Agreement (Industry Contracts Division)
- Data and Safety Monitoring Plans and Boards
- General Data Protection Regulation (GDPR)
Federal & NIH Policies
UCSF Resources
- Data Resources (UCSF Data)
- Data Death Files
Device, Drug and Technology Guidance
- Investigational Devices
- Investigational New Drugs and Biologics
- Mobile Apps
- Significant vs. Non-Significant Risk Devices
- ChatGPT/ Large Language Models (LLM)/ Artificial Intelligence (AI)
Education and Training
- CITI Training
- CRC Council
- Education Opportunities
- Roles and Responsibilities
- In-Service Education Training
IRB Review
IRB Submissions
- New Study
- Modification
- Continuing Review
- Emergency Use & Compassionate Use
- Expanded Access for Medical Devices, Drugs, and Biologics in a Non-Emergency Situation (Compassionate Use)
- Reportable New Information (RNI): Protocol Violation, Adverse Event, Safety Reports
- Study Closeout Report
- Benioff Children's Hospital Oakland
Research Gateway IRB
- IRB Application Templates, Help Guides, and Supplemental Forms
- Submission Freeze
- Transition Guidance
- Training, System User Guides, and Guidance Sheets
Quality Improvement Unit (QIU)
- Adverse Event, Monitoring, Protocol Violation or Incident
- Post Approval Reporting Requirements Summary Sheet
- Reporting Research Related Concerns and Complaints & Responding to Research Related Concerns and Complaints
- Research Tools and Checklist
- Resources for FDA Audit