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Emergency Use of an Investigational Product

Emergency Use of an Investigational Product forms are available in Microsoft Word Format. To download a form, click on the link provided in the form title.

Instructions for Emergency Use

  
 

Form

 

Emergency Use Guidelines

Application Forms/ Templates

(1) Cover Memo
   
 

Form

Type of Review
 

Cover Memo: IRB Form #1

Full Board/Expedited

 

(2) Emergency Use
  
 

Form

 

Emergency Use Report Form: IRB Form #11

 

(3) Investigator Statement of Compliance
  
 

Form

 

FDA Form 1572

 

Investigator Agreement (IDE trials) - This form is supplied by the sponsor when an IDE is involved.

 

(4) Informed Consent
  
 

Form

 

Emergency Use Consent Template

  
 

Completion Guidelines/Instruction Sheet

 

Customization Guidelines: MHRI IC Template

 

Lay Terms for Use in Informed Consent

 

(5) HIPAA
  
 

Form

 

Emergency Use HIPAA Authorization Template

  
 

Completion Guidelines/ Instruction Sheet

 

Guidelines for Use of HIPAA forms

 

(6) Investigational Product
  
 

Form

 

MHRI Investigational Drug/Biologic Information Sheet

 

MHRI Investigational Device Information Sheet

Resources and Guidelines/ Instruction Sheets

(1) Protocol Review/ Submission
  
 

Emergency Use Guidelines

 

(2) Informed Consent
  
 

Form

 

Customization Guidelines: MHRI IC Template

 

Lay Terms for Use in Informed Consent




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