• UCLA Health
  • myUCLAhealth
  • School of Medicine
Office of Compliance Services

Office of Compliance Services

Office of Compliance Services
  • About Our Program
    • Message from the Vice Chancellor
    • Code of Conduct & Statement of Ethics
    • Organizational Structure
    • Contact Us
    • Staff Spotlight
    • Program Description
    • Hotline Information
    • Conflict of Interest/Vendor Relations
    • Other Informative Sites
  • Compliance Services
    • Clinical Research Billing
    • Hospital Compliance
    • Professional Compliance
    • Frequently Asked Questions
    • EMTALA Compliance Program
  • Information Security & Privacy
    • Device Security
    • Additional Resources
    • HIPAA Training
    • Forms
    • Guidance and Policies
    • Frequently Asked Questions
  • Education & Training
    • Clinical Research Compliance Training
    • New and Current Faculty Training
    • EMTALA Training
    • HIPAA Training
    • Ethics Briefing/Conflict of Interest Training
    • Clinical Laboratory and Pathology Compliance Training
    • Advisory Notices
    • Webinars
  • Policies & Procedures
    • Clinical Laboratory and Pathology Compliance
    • Ronald Reagan UCLA Medical Center (Westwood)
    • Resnick Neuropsychiatric Hospital at UCLA
    • UCLA Santa Monica Medical Center
  • Compliance Tips
    • Frequently Asked Questions
    • Information Security Tips
    • Privacy Tips
    • Hospital, Physician, and Clinical Research Tips
  • UCLA Health
  • myUCLAhealth
  • School of Medicine

Office of Compliance Services

Frequently Asked Questions

  1. Home
  2. Frequently Asked Questions

Frequently Asked Questions

Share this

What type of records does the FDA require the investigator to retain for studies involving Significant Risk devices?

The investigator must maintain accurate and complete records relating to the investigation. These records include:

  • all correspondence with the sponsor, other PIs, the IRB, FDA and other regulatory correspondence, etc.
  • records of receipt, use, or disposition of the investigational device
  • records of each subject's case history and exposure to the device
  • the protocol and documentation (date and reason) for each deviation from the protocol (if any)
  • any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation


Like Us on Facebook Follow Us on Twitter Subscribe to Our Videos on YouTube Follow us on Instagram Connect with Us on LinkedIn Follow us on Pinterest
UCLA Health hospitals ranked best hospitals by U.S. News & World Report
  • UCLA Health
  • Find a Doctor
  • School of Medicine
  • School of Nursing
  • UCLA Campus
  • Directory
  • Newsroom
  • Subscribe
  • Patient Stories
  • Giving
  • Careers
  • Volunteer
  • International Services
  • Privacy Practices
  • Nondiscrimination
  • Billing
  • Health Plans
  • Emergency
  • Report Broken Links
  • Terms of Use
  • 1-310-825-2631
  • Compliance Hotline
  • Contact Us
  • Your Feedback
  • Report Misconduct
  • Get Social
  • Sitemap
Like Us on Facebook Follow Us on Twitter Subscribe to Our Videos on YouTube Follow us on Instagram Connect with Us on LinkedIn Follow us on Pinterest

Sign in to myUCLAhealth