New Study | Initial Review Applications

• Application for Behavioral Study Review
• Application for Bio-Medical Study Review
• Application for Exemption from IRB Review
• Application for Expedited Review

Supplementary Applications

• Supplementary Application for Research Involving Children
• Supplementary Application for Research Involving DNA/Tissue/Sample Banks
• Supplementary Application for Research Involving Pregnant Women, Human Fetuses, and Neonates
• Supplementary Application for Research Involving Prisoners
• Supplementary Application: Indications for Investigational New Drug (IND) and Investigational Device Exemption (IDE)
• Supplementary Application: Investigational Drug Information Record

Financial Disclosure Form

• Conflict of Interest in Research: Financial Disclosure Form

Post-Approval

• Application for an Amendment (Change)/Addendum (New)
• Application for Continuing Review
• Application for Final Review
• Deviation Form
• Serious Adverse Event (SAE)/Unanticipated Risk Report Form

Templates

• Exempt Protocol Template
• Sample Assent Form
• Sample Informed Consent Document