Our Services

• Data Resources
• Device, Drug, and Technology Guidance
• Education and Training
• IRB Review
• IRB Submissions
• Research Gateway IRB
• Quality Improvement Unit (QIU)
• Stem Cell (GESCR)
• Working with other Institutions

Data Resources

Security & Storage

• Electronic Data Security
• Data Storage/Retention
• De-identification and Confidentiality of Research Data

Agreements & Governance

• Data Use Agreementexternal site (opens in a new window) (Industry Contracts Division)
• Data and Safety Monitoring Plans and Boards
• General Data Protection Regulation (GDPR)

 Federal & NIH Policies

• NIH Data Management and Sharing Policy (NIH DMS Policy)
• Genomic Data Sharing
• Data Sharing

 UCSF Resources

• Data Resourcesexternal site (opens in a new window) (UCSF Data)
• Data Death Files

Device, Drug and Technology Guidance

• Investigational Devices
• Investigational New Drugs and Biologics
  • Expanded Access to Unapproved Drugs for Treatment
• 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 Members
  • Rosters, Meeting Dates
• IRB Review Process
  • Does My Research Need IRB Review?, Levels of Review, Common Rule, Expiration Dates, IRB Review Fees
• Non-Human Research
• Quality Improvement (QI) and Quality Assurance (QA)

IRB Submissions

• New Study
• Modification
• Continuing Review
• Emergency Use & Compassionate Use
• Expanded Access to Unapproved Drugs for Treatment
• 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

Stem Cell (GESCR)

• Consent Guidance
• GESCR Submission
• Regulatory Q&A
• Research Requiring Review
• Using Stem Cell Line

Working with other Institutions

• Current External IRBs
• Single IRB (sIRB) Mandate
• Relying on other IRBs
• Research at the SFVAHCS
• UCSF Affiliates
• UCSF as IRB of Record