Forms

Adding/Removing Investigators

Amendment Form

Clinical Trials Protocol Template

Data & Safety Monitoring Review Form

Emergency Use Documents

• Emergency Use IRB Notification
• Emergency Use ICF Template

Expedited Review Determination Guidance

FCOI Disclosure for all listed personnel

Final Report Form 

Informed Consent Form Templates and Consent Waiver Documents

• Blood or Tissue Consent Template
• Emergency Use ICF Template
• Main ICF Template
• Main ICF Template Non-Therapeutic Survey Research
• Portuguese Short Form Consent Template
• Request for Waiver of Subject Authorization
• Short Form Template
• Spanish Short Form Consent Template
• Surrogate Consent
• Vietnamese Short Form Consent Template

Initial Application Documents

• IRB HDE Application
• IRB Initial Application
• IRB Submission Checklist

Lost to Follow Up Letter Template

Periodic Review Form

SAE and UAP Reports

• Adverse Event Form
• UAP Report Form

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Adding/Removing Investigators

Amendment Form

Expedited Review Determination Guidance

Final Report Form 

Informed Consent Form Templates and Consent Waiver Documents

• Main ICF Template
• Short Form Template
• Spanish Short Form Consent Template

Initial Application Documents

• IRB Initial Application
• Request for IRB Exemption
• HIPPA De-Identification Certifications Form
• Request for Waiver of Subject Authorization Form

Resident Access to Data Program Form

Periodic Review Form

SAE and UAP Reports

• Adverse Event Form
• UAP Report Form

IRB Exempt Completion Memo Template

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