Our Services

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

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
• Protocol Enrollment Exception
• Emergency Use
• Study Closeout Report
• Benioff Children's Hospital Oakland

iRIS

• Accounts and Access
• iRIS Help (MyAccess login required)
• Online Application System: Info and FAQs
• Responding to Stipulations

Research Gateway

• Research Gateway Transition

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