• Education Opportunities
• CITI Training
• In-Service Education Training
• IRB Research Tools and Checklists
• Past Classes and Slides
• Other Education Resources

Education Opportunities

Explore our Education Opportunities page for information on upcoming classes and access to materials from previous sessions.

CITI Training

All Key Personnel at UCSF or affiliated sites involved in Human Subjects Research are required to complete CITI training in human subjects protection (HSP). This requirement applies to Key Study Personnel on Exempt, Expedited, and Full Board studies. To check your CITI training status and for detailed instructions on completing or updating your training, please refer to the following lists:

In-service Education Training

Need a department-specific training session? In-Service education ensures that everyone receives consistent information on key topics. To request a session, please complete the Request for In-Service Training form.

IRB Research Tools and Checklists

These tools and checklists are designed to support compliance and streamline study processes:

Submission and Reporting:

• Initial Submission Checklist
• Post Approval Reporting Requirements

Consent:

• Consent Form Checklist for Using a Non-UCSF Consent Form
• NIH GDS Policy Consent Checklist

Study-Specific Documents:

• UCSF Investigator Checklist for IDE Exempt, Non-Significant, and Significant Risk Device Studies
• UCSF Routine On-Site Review Form

Quality and Compliance Documentation:

• Quality Management Plans
• Regulatory Binder Requirements
• Delegation of Authority Documentation Log
• Drug or Biologic Dispensing / Accountability Log
• Screening / Enrollment / Withdrawal Log
• UCSF Corrective and Preventative Action (CAPA) Training Log
• Device Dispensing / Accountability Log
  • Example: Study Events Tracking Form
  • Example: Tracking System for Deadlines and Reporting
• FDA and OHRP Inspections: Please notify UCSF upon receiving the call or letter to schedule the inspection. See the UCSF Clinical Research HUB for more information about whom to contact and how to prepare for the inspection.

Past Classes and Slides

Note: The IRB was formerly known as the Committee on Human Research (CHR), which is the term used in some of these presentations.

Other Education Resources

UCSF

• Suggested Training for Clinical Research: The UCSF Clinical Research Training document provides essential and supplementary training resources for Clinical Research Coordinators (CRCs), covering areas like HIPAA, informed consent, Good Clinical Practice, and data security. Each training component includes links, requirements, and estimated completion times.
• Clinical Trials Operations (CTO):The Clinical Trials Operations (CTO) Unit serves as an institutional representative and advocate for the UCSF clinical trials community. The CTO aims to identify, assess and prioritize barriers for inclusive and efficient trials, and steward solutions to challenges that adversely impact clinical trials operations. View upcoming and past events. 
• Responsible Conduct of Research: A guide for RCR training for UCSF learners and researchers at all levels — graduate students, postdocs, and faculty — and a resource for NIH training grant faculty and administrators. 
• UCSF Clinical Research Resource HUB: Training
• Clinical and Translational Science Institute (CTSI) 

Other Groups or Institutions

• Center Watch Resources
• University of Michigan Online Course: Valid Consent/Refusal to Participate in Research

Federal Government

• Office of Human Research Protections (OHRP): Education Resources (Includes In-Person Events and Online Educational Opportunities)
• NIH: Educational Materials About Clinical Trials

National Conferences and Workshops

• Society of Clinical Research Associates (SoCRA) Educational Opportunities Calendar
• Public Responsibility in Medicine and Research (PRIM&R) Conferences