Quality Assurance & Quality Improvement

FDA Guidance Documents

• Adverse Event Reporting to IRBs (PDF)
• Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials (PDF)
• Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF)
• Clinical Investigator Administrative Actions – Disqualification (PDF)
• Frequently Asked Questions About Medical Devices (PDF)
• Frequently Asked Questions – Statement of Investigator (PDF)
• FDA Inspections of Clinical Investigators (PDF)
• Significant Risk and Nonsignificant Risk Medical Device Studies (PDF)