Single Patient Use of an Investigational Product

Instructions for Single-Patient Use

Form

Single Patient Use Instructions

Form

Cover Memo: IRB Form #1

Form

New Protocol Review Request: IRB Form #2

Form

Sponsor IND/IDE Statement of Assurance

Statement of Assurance Completion Guidelines

Form

FDA Form 1572

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

Form

FDA Form 3455

Form

MHRI Informed Consent Template

MHRI-GU Joint Informed Consent Template

MHRI Genetic Consent Template

MHRI Assent Template

Form

HIPAA Authorization Template

Waiver Application

Form

MHRI Investigational Drug/Biologic Information Sheet

MHRI Investigational Device Information Sheet

Instruction Sheet

Single Patient Use Instructions

IRB Reviewer Checklist for New Protocols

New Project Submission: Full Board Review

Department Administrator Checklist

Form

Customization Guidelines: MHRI IC Template

Lay Terms for Use in Informed Consent

IRB Reviewer Checklist - Elements of an IC Document

Form

HIPAA Decision Matrix