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)