All | Research A to Z

Guidance

Jun 19, 2023

Single IRB (sIRB) and Cooperative Multi-Site Research

sIRB Timing, Fees and Budgeting When requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date. See section “IRBMED as the sIRB (accepting oversight)” of this guidance...

Tags: Regulatory Sponsor

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

Jul 1, 2022

Michigan Medicine Clinical Research Position Statement

Industry sponsors often agree to pay for the costs of items and services that arise from research-‐related injuries. Sometimes the promise to pay is conditioned upon the receipt of a denial from another payer or stated as a conditional payment if...

Tags: CRAO

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

Guidance

Jun 4, 2021

Information Blocking in a Blinded Study

Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes...

Tags: MiChart OnCore Support Participant Management