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Guidance

Nov 2, 2020

FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...

Templates

May 11, 2020

Humanitarian Use Device (HUD) Informed Consent Template

This template should be used when submitting the Humanitarian Use Device (HUD) informed consent documents. The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the...

Guidance

May 11, 2020

Humanitarian Use Device Requirements for U-M Physicians & Investigators

The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals...

Policies

Nov 21, 2019

University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...

Tags: MICHR

Guidance

Jun 1, 2018

Emergency Research (Planned and Approved) with Exception from Informed Consent

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency...

Guidance

May 7, 2018

FDA Expanded Access Program at the University of Michigan

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu The FDA Expanded Access program allows a...

Policies

May 26, 2017

Statement of Practice: Sections 15 and 16 of IRB Application

Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...

Templates

Mar 29, 2017

FDA Expanded Access Informed Consent Template

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...

Guidance

Dec 13, 2016

Emergency Use of a Test Article in Life-Threatening Circumstances

This guidance describes the circumstances regarding Expanded Access Emergency Use ( Emergency Use ) of an investigational product (drug, biologic , or device) and the procedures to be followed before or immediately following the emergency use of an...

Guidance

Mar 8, 2013

Electronic Records and Electronic Signatures (21 CFR Part 11)

The regulations in 21 CFR Part 11 set forth the criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper...

Guidance

Aug 16, 2012

Forms

The forms below are designed for use with various IRBMED submissions.

Guidance

Apr 17, 2012

Federal Regulations

Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 -- Institutional Review Boards 21 CFR 11 -- Electronic Records; Electronic Signatures 21 CFR 312 -- Investigational New Drug (IND)...

Guidance

Jul 10, 2020

eResearch Cross-Reference Table

These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...