The University of Michigan Samuel & Jean Frankel Cardiovascular Center and the CVC Clinical Research Group (C3RG) invite you to attend the C3RG seminar series “FDA Inspections: The More Things Change, The More They Stay The Same,” presented by Diane Wilson, Regulatory Manager, Office of Regulatory Affairs, UMMS.

Lunch will be provided for those who are registered on a first-come, first-served basis. There is no cost for this event.

When: Tuesday, April 9
Time: Noon to 1 p.m.
Where: Danto Auditorium

Register here for this event.

Join the Data Office for a brand-new live online tutorial that will cover the basics of EMERSE (the Electronic Medical Record Search Engine), an easy-to-use, self-service search engine for the free text documents coming from Michigan Medicine’s electronic health record systems.

Get more information at the website or by email.

When: Wednesday, April 10
Time: 10-11 a.m.
Location: Online

RSVP here for this tutorial.

Are you interested in partnering with industry on a clinical trial, but are unsure of where to start? Have you been hesitant to pursue an industry trial because you’re not sure who can help here at U-M or whether this is a good use of your time? Would you like to learn more about how to effectively interact with sponsors?
 

Join us for the two-part series, Working with Industry. Featuring an expert panel discussion on partnering with industry sponsors, you’ll learn more about the ins-and-outs of industry-sponsored trials here at U-M, including how the teams in the Clinical Trials Support Office and Fast Forward Medical Innovation can help.
 

Part One will showcase first-hand accounts from faculty and industry professionals. Save the date for Part Two on May 28.

When: Thursday, April 11
Time: 5-7 p.m.
Location: 2901 Taubman Health Sciences Library

Find out more and register here for this event.

All trials that use a CTSU will receive a complimentary service to register the trials on ClinicalTrials.gov. If you are using a CTSU, you do not need to take this workshop. This workshop session, open to PIs, study coordinators, and research administrators, will be a hands-on opportunity to walk through how to register a clinical trial on www.ClinicalTrials.gov in the company of others, sharing experiences, tipsheets, best practices, and lessons learned. We’ll start with how to get into the system, and give time at the end to start registering your trials. We’ll also preview what information you will need if you will have to post results later.
 

Please come with your personal account already set up in ClinicalTrials.gov and bring your HUM numbers, and we’ll roll up our sleeves and get started.

A laptop is required.

This computer lab session for principal investigators, assistants, study team members, statisticians, or ClinicalTrials.gov administrators will provide hands-on experience with sample results reporting as well as assistance with reporting your own study’s results. Please come with an active, working account on www.ClinicalTrials.gov, and if you wish to begin entering results, please bring copies of draft or completed articles as well as other major data collections that you have from which to enter your results.
 

As a prerequisite, please complete the Registering Studies in ClinicalTrials.gov Workshop prior to enrolling in this training.
 

A laptop is required.

Here is a selection of the many upcoming workshops offered by IRBMED. To see additional offerings, click here.
 
Regulatory Requirements for Research with Children, Pregnant Women, Fetuses, Neonates and Prisoners (Level II)
This course will examine the additional regulatory requirements for conducting research involving children, pregnant women, fetuses, neonates, and prisoners. The course will include the requirements for enrolling these populations in a research project; obtaining informed consent, assent, and parental permission; and the required procedures when an already enrolled subject becomes incarcerated.

When: Friday, April 12
Time: 9-10 a.m.
Where: 2C224 University Hospital 

Register here for this workshop.
 
Reporting Adverse Events, ORIOs, and Unanticipated Problems (Level I)
This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and review the requirements of reporting such events to the IRB via eResearch. This session will also include a discussion on when it is appropriate to use a study specific AE reporting plan as opposed to the standard U-M time table for reporting adverse events to the IRB.
 
When: Friday, April 19
Time: 9-10 a.m.
Where: 2C224 University Hospital 
 
Register here for this workshop.

The University of Michigan HomeLab is a homelike simulated research lab with comprehensive research support provided by the BioSocial Methods Collaborative. The HomeLab offers a fully functional apartment with an extensive suite of measurement tools (sensors) and features of the home that can be controlled to help facilitate human-subjects research. Learn more about how to use the HomeLab in your research here.

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