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 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 [email protected] The FDA Expanded Access program allows a...
Guidance Apr 17, 2012 Federal Regulations - ARCHIVED 04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...
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 Aug 22, 2022 Emergency Use of a Test Article in Life-Threatening Circumstances This guidance describes the circumstances regarding 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 investigational product. Emergency... Tags: Regulatory MICHR Investigator Initiated
Guidance Feb 15, 2023 Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements This document provides guidance on the monitoring requirements for non-significant risk (NSR) device studies that are initiated by UM investigators and under IRBMED oversight . It also provides instructions on completing the IRB application for the... Tags: Regulatory Study Coordinator Principal Investigator MICHR Study Teams Investigator Initiated
Guidance Dec 18, 2020 Investigational In Vitro Diagnostics (IVDs) utilized in Clinical Investigations of Therapeutic Products Human subjects research applications received by IRBMED include clinical investigations of therapeutic products that propose to utilize in vitro diagnostic (IVD) tests or assays. PDF version
Guidance Oct 27, 2023 Other Reportable Information or Occurrence (ORIO) Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED . Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in...
Guidance Sep 13, 2021 Protocol Resources The study protocol should comprise all the key information about study conduct, including but not limited to rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study... Tags: Protocol Regulatory Study Coordinator Study Teams U-M resource
Policies Aug 5, 2019 Statement of Practice: Ancillary Approval & Final IRBMED Approval Click here for PDF version .
Guidance Jul 14, 2016 Resources - ARCHIVED 07/12/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant internal and external resource websites. The lists below provide direct links to resources both within the University of Michigan and outside the...
Guidance Nov 14, 2011 Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g., DSMB, FDA) The table below presents instructions and guidance on informing IRBMED of reports to or from oversight bodies.
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...
Guidance Nov 28, 2022 Updating IRB applications when Researcher(s) Leave U-M When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in... Tags: Regulatory Principal Investigator
Guidance Feb 22, 2021 International Council for Harmonisation: Good Clinical Practice (ICH-GCP) The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6(R2) Guidelines. International Council for Harmonisation (ICH) Good Clinical Practice ( GCP ) standards (ICH-GCP) standards are fully...
Templates Apr 15, 2024 Specialty Informed Consent Templates Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if... Tags: Regulatory Study Coordinator Principal Investigator Participant Management Study Teams
Guidance Sep 13, 2023 Research Involving Genetic, Genomic, and/or DNA Collection or Analysis This guidance document outlines IRB expectations for research involving genetic analysis which generates human genetic information through analysis of human biospecimens. For this guidance, the relevant human genetic information includes heritable...
Guidance Aug 10, 2023 Reporting Time-Sensitive Modifications NOTE: The following guidance does not apply to studies where IRBMED is relying on an external IRB for regulatory oversight ("ceding" IRB oversight). If your study is ceded, you must reach out to the IRB of Record for guidance and then submit an...
