Data and Safety Monitoring Boards and Data Safety Monitoring Plans Register
Date:
Tuesday, January 21, 2025
Time:
10:30 am to 11:30 am
Location:

Virtual

A woman participating in a zoom event
About This Event

Presented by IRBMED, a unit of the Medical School Office of Research, this course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP. A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data. 


Tags Office of Research
Upcoming Events View All Upcoming Events
Federal and Institutional Requirements for Human Subject Research
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
A person takes notes during a Zoom session.
Elements of Informed Consent
This course offers an overview of informed consent in human subject research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal requirements.
A person sits at a laptop at BSRB.
Introduction to eResearch
This course is intended for those unfamiliar with eResearch, the university’s electronic research administration site. This course will provide a basic knowledge of working in and using eResearch while examining the process for creating and submitting an initial project application.
A computer screen showing multiple people participating in a zoom event
Advanced Genomics and Bioinformatics Cores Holiday Open House
Join us at our Holiday Open House event, where innovation meets expertise! This is an opportunity for researchers to explore our cutting-edge facilities and discover the exciting advancements in Single Cell, Spatial, and Next Generation Sequencing (NGS) technologies.
Advanced Genomics Core staff demonstrate equipment.
Waivers, Alterations, and Alternative Forms of Informed Consent
This course offers an overview of some special situations relating to informed consent. Specifically, waivers and alterations of informed consent, waivers of documentation of informed consent, and obtaining consent from non-English speakers.
A woman participating in a zoom event
Research Operations, Management & Strategy (ROMS) Fellowship Information Session
The Research Operations, Management & Strategy (ROMS) Fellowship sponsored by the UMMS Office of Research is now recruiting for the 2025-2027 cohort and is hosting an upcoming information session about the program.
A speaker addressing a class in the seminar rooms at BSRB
Reporting AEs, ORIOs, and Unanticipated Problems
This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and how such events impact risk to subjects. Additionally, the course will review the requirements of reporting such events to the IRB and other entities.
A man participating in a zoom event
Amendments and Continuing Reviews
This course is a follow-up to Initial Project Applications and will examine the process for submitting amendments and scheduled continuing reviews to IRBMED using eResearch once a project’s initial application has been approved.
A woman participating in a zoom event
Data and Safety Monitoring Boards and Data Safety Monitoring Plans
This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP. A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data.
A woman participating in a zoom event
Storage and Retention of Data
This course will review the fundamentals of maintaining confidentiality of subject data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de- identified datasets.
A woman sitting at a desk participating in a zoom event
Introduction to sIRBs
This course will identify the Single IRB model for Multi-Site research, show the regulatory requirements of sIRB review and the exceptions to sIRB requirements, and explain sIRB requests of IRBMED as sIRB (accepting oversight), External IRB as sIRB (ceding oversight), and UofM as the Coordinating Center.
A person with a laptop and a cup of coffee participating in a zoom event
FDA Research Involving Drugs and Devices
This course will review what research is subject to FDA oversight, highlight the differences between OHRP and FDA regulations, learn the responsibilities of sponsors, investigators, and the IRB when conducting and reviewing research involving drugs and devices, and examine the requirements for conducting research with a drug or biologic/medical device.
A person smiles at their laptop.
Not Regulated, Secondary Use, and Umbrella Applications
This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
A man participating in a zoom event
OHRP’s Subparts B, C, and D - Special Populations
This course will examine the additional regulatory requirements for conducting research involving pregnant women, fetuses, neonates, children, and prisoners, including the requirements for these populations in a research project and obtaining informed consent.
Someone using a laptop and a smart phone during a zoom meeting
Federal and Institutional Requirements for Human Subject Research
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
A person takes notes during a Zoom session.
Elements of Informed Consent
This course offers an overview of informed consent in human subject research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal requirements.
A laptop shows many people participating in a Zoom event.
Hearing, Balance and Chemical Senses Seminar Series
Every week, the Kresge Hearing Research Institute hosts a guest speaker, who presents as a part of the KHRI Hearing, Balance and Chemical Senses Seminar Series.
Event runs October 15, 2024 - November 18, 2025
Cardiovascular Grand Rounds
CVM Grand Rounds is a lecture series aiming to present relevant clinical and academic work related to cardiovascular conditions. 
Event runs November 14, 2024 - November 13, 2025
Ganesh Lab
Have a Seat
Have a Seat is a weekly guided meditation program that takes place virtually.
Event runs April 11, 2024 - November 13, 2025
Smooth Stones with Water
15th Annual Diane Baker Alumni Award & Lecture
Cracks in the Foundation: Building a More Inclusive Genetic Counseling Education System
Hearing, Balance and Chemical Senses Seminar Series
Every week, the Kresge Hearing Research Institute hosts a guest speaker, who presents as a part of the KHRI Hearing, Balance and Chemical Senses Seminar Series.
Event runs October 15, 2024 - November 18, 2025
Dr. Max Wilkinson, Massachusetts Institute of Technology
Join the Department of Biological Chemistry for a seminar presented by Dr. Max Wilkinson from the Massachusetts Institute of Technology.
December fMRI Speaker Series
Featuring Dr. Gagan S. Wig, Associate Professor, The University of Texas at Dallas.
Wednesday Seminars by Trainees Series (WeST)
Part of the Wednesday Seminars by Trainees Series (WeST)
MIP Seminar Series - Karyn Esser, PhD
Part of the MIP Seminar Series
CCMB Seminar: Zhiping Weng, PhD
Join the U-M CCMB Seminar Series on bioinformatics, Wednesdays at 4 PM EST, Palmer Commons. Featuring guest speakers, sponsored by Computational Medicine & Bioinformatics.
Cardiovascular Grand Rounds
CVM Grand Rounds is a lecture series aiming to present relevant clinical and academic work related to cardiovascular conditions. 
Event runs November 14, 2024 - November 13, 2025
Ganesh Lab
Visiting Scholar Program: Erez Cohen, PhD
The UM Skin Research Center Visiting Scholars Program welcomes Dr. Erez Cohen. This seminar series invites accomplished and diverse speakers engaged in cutting-edge work in various research fields to speak and present their work.
Have a Seat
Have a Seat is a weekly guided meditation program that takes place virtually.
Event runs April 11, 2024 - November 13, 2025
Smooth Stones with Water
Tools & Technology Seminar: Tomer Stern
“Whole Embryo Mapping of Cell Activities and its Integration with Comprehensive Genetic Identity” presented by Tom Stern (Dentistry)
M&I Seminar Series: Carole Parent
Carole Parent, University of Michigan