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Single Patient Use of an Investigational Product

Single Patient 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 Single-Patient Use

   
 

Form

 

Single Patient Use Instructions

Application Forms/ Templates

 
(1) Cover Memo
     
 

Form

Type of Review
 

Cover Memo: IRB Form #1

Full Board/Expedited
     
(2) Protocol Review
     
 

Form

Type of Review
 

New Protocol Review Request: IRB Form #2

Full Board Review
     
(3) Sponsor IND/IDE Statement of Assurance
   
 

Form

 

Sponsor IND/IDE Statement of Assurance

 

Statement of Assurance Completion Guidelines

 
(4) Investigator Statement of Compliance
   
 

Form

 

FDA Form 1572

 

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

 
(5) Conflict of Interest
   
 

Form

 

FDA Form 3455

 
(6) Informed Consent
   
 

Form

 

MHRI Informed Consent Template

 

MHRI-GU Joint Informed Consent Template

 

MHRI Genetic Consent Template

 

MHRI Assent Template

   
(7) HIPAA
   
 

Form

 

HIPAA Authorization Template

 

Waiver Application

   
(8) Investigational Product
   
 

Form

 

MHRI Investigational Drug/Biologic Information Sheet

 

MHRI Investigational Device Information Sheet

Resources and Guidelines/ Instruction Sheets

 
(1) Protocol Review/ New Project Submission
   
 

Instruction Sheet

 

Single Patient Use Instructions

 

IRB Reviewer Checklist for New Protocols

 

New Project Submission: Full Board Review

 

Department Administrator Checklist

 
(2) Informed Consent
   
 

Form

 

Customization Guidelines: MHRI IC Template

 

Lay Terms for Use in Informed Consent

 

IRB Reviewer Checklist - Elements of an IC Document

 
(3) HIPAA
   
 

Form

 

HIPAA Decision Matrix

   

Contact Information

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