Obtaining Approval Does this need IRB Review? PI Responsibilities PI Eligibility Levels of Review Items to include in your IRB submission IRB Training Recruitment Informed consent Forms and Checklists Common Mistakes After Approval Record Keeping / Data Management Modifications / Renewals Reportable Events Post Monitoring Program Study Expiration / Closure General Guidance HHS FAQ IRB FAQs Use of Deception IRB Glossary FDA Information Sheet – Medical Devices FAQ FDA Information Sheet – Medical Devices Risks HHS Resources Certificates of Confidentiality Exemption Categories Benign Behavioral Interventions
