Guidance
Jun 17, 2011

AHRQ: Mandatory Use of Data Safety and Monitoring Plans

The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...
Guidance
Oct 26, 2009

Reconsenting Study Subjects

Informed consent is an ongoing process requiring you to provide subjects with continual information and clarification, which will enable them to decide whether to continue participating in research studies. Encourage all subjects to ask questions...
Guidance
Jan 3, 2008

Record Keeping Guidelines

Investigators frequently ask how long they should keep research records after a study has ended. Because different regulations apply to different types of studies there is not a simple answer to this question. Ten years is a safe default standard,...
Guidance
Oct 2, 2007

Study-Specific Adverse Event (AE) Reporting Plans

There are two types of studies for which the principal investigator should consider using a study-specific AE reporting plan in order to reduce or streamline the reporting burden on the study team: Sponsored studies that include a detailed AE...
Guidance
Jul 24, 2007

Guidelines For Using Magnitude Of Harm In Categorizing Risk Level

The probability* and magnitude of harm or discomfort anticipated in the research and not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or...
Guidance
Sep 5, 2005

Research and Non-English Speaking or Reading Subjects

Many patients at the University of Michigan Health System do not speak English or lack the fluency to understand medical and scientific information presented in English. In order for such a patient to participate in a research study, steps must be...
Guidance
Oct 17, 2016

eResearch Cross-Reference Table

This document provides direction to general eResearch sections and application materials that may be indicated as part of the requested changes.

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