Strategic Partners & Resources

A graphic of cogs showing ctso/ctsu relationship to strategic partnersThe Clinical Trials Support Office has strategic partnerships with various campus enterprises with deep expertise to better serve our study team’s needs. Our strategic partners enhance the clinical research experience for our study teams by assisting with education & training, billing, regulatory compliance, database management, and more. Take advantage of the following resources to strengthen your clinical research and increase your career development. 

STRATEGIC PARTNERS & RESOURCES

Calendar Review & Analysis Office (CRAO)
CRAO completes a Medicare Coverage Analysis (MCA) and partners with the CTSUs to create billing calendars for all Human Subject Clinical Trials that have billable items and services to ensure consistency with the five core documents which are the Protocol, Informed Consent, Billing Calendar, Budget, and Contract and to allow for the appropriate adjudication of charges.

ClinicalTrials.gov
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. 

Clinical Trial Registration Requirements and Decision Trees
View this page for an overview of the steps researchers must take to register their clinical trials on ClinicalTrials.gov. 

FDAAA 801 Requirements
This site summarizes the clinical trial registration and results information submission requirements for Section 801 of the Food and Drug Administration Amendments Act of 2007. This page also covers information about the Final Rule for clinical trials registration and results information submission which clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain trials to ClinicalTrials.gov. 

International Committee of Medical Journal Editors (ICMJE) Requirements
The ICMJE requires and recommends that all medical journal editors require registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. This resource provides the ICMJE publication requirements for clinical trials.

UMOR Research Ethics & Compliance - Clinical Trials Registration & Results Reporting
The webpage offers useful information on what U-M investigator-initiated clinical trials need to register, who must register clinical trials, and how to register and report results on ClinicalTrials.gov. The webpage also includes contact information for U-M offices that offer ClinicalTrials.gov support and resources. 

eResearch
eResearch is the University of Michigan's site for electronic research administration.

Institutional Review Boards (IRBMED)
IRBMED is charged with protecting the rights and welfare of participants in clinical trials and other human subjects research studies. IRBMED is responsible for monitoring compliance with federal and state laws, university policies, and ethical principles (particularly those articulated in the Belmont Report).

MiChart Research Resources
A knowledge base and resource repository for clinical users of Michigan Medicine's electronic health record system, MiChart. The site contains MiChart tip sheets, reference documents, training videos, information regarding updates and upgrades to the system, and much more.

The Michigan Diabetes Research Center (MDRC)
The Michigan Diabetes Research Center (MDRC) Recruitment Service facilitates identification of potential subjects with diabetes for clinical studies/trials at the University of Michigan by using the MDRC Diabetes Research Registry, MiChart Recruitment Alerts, and the Blue Cross Network. The MDRC Diabetes Research Registry consists of over 7800 of Michigan Medicine’s ambulatory care clinics’ diabetes patients interested in participating in clinical research. For more information about the Michigan Diabetes Research Center and how to use their services contact diabetesresearchregistry@umich.edu

Michigan Institute for Clinical & Health Research (MICHR)
MICHR is here to enable & enhance clinical research at U-M. MICHR does this by being a catalytic partner that educates, funds, connects & supports research teams here and beyond. 

MICHR Resource Center
Explore this site to find resources that MICHR has created to help study teams, including best practices, standard operating procedures (SOPs), templates, toolkits, and more.

UMHealthResearch.org
Use UMHealthResearch.org to connect your study to over 30,000 volunteers who hope to help research. UMHealthResearch is a free, mobile-friendly, and engaging web application managed by MICHR. It takes 8 to 10 minutes to post a clinical trial. While U-M does not currently mandate that clinical researchers post their studies on umhealthresearch.org, having many trials in one location creates an accessible and easy to understand experience for research patients.

Children’s Neurodevelopmental Assessment Core
Working with MICHR, the Children’s Neurodevelopmental Assessment Core (C-NAC) supports outcome assessments for clinical trials that include measures of development, cognition, quality of life, adaptive functioning, and mental health.

NIH Clinical Trials Resources
The National Institute of Health provides in-depth guidance for investigators and staff of clinical trials, including several protocol templates, NIH definition decision tree & FAQ, enrollment guidance, and more. Click here to view NIH Clinical Research Toolkit & Educational Materials. 

Office of Research & Sponsored Projects (ORSP)
The Office of Research and Sponsored Projects enables and safeguards the conduct of research and other sponsored activity for the University of Michigan.

Clinical Trial Master Agreements
Master Clinical Trial Agreements (MCTAs) provide agreed-upon terms and conditions between the University and a Sponsor. We now have MCTAs with the following sponsors. The Office of Research and Sponsored Projects is continually working on revisions, renewals, and/or new agreements.

Research Pharmacy
The U-M Research Pharmacy is a service provided by the Department of Pharmacy Services and supported by Michigan Medicine, to assist investigators in the handling of drugs used in clinical research studies. Click here to learn about Research Pharmacy Policies.

U-M Nutrition Obesity Research Center (NORC)
The mission of UM Nutrition Obesity Research Center (NORC) is to identify improved methods for the prevention and treatment of obesity, supporting a continuum of care from primary, secondary, tertiary prevention.

 

Questions?

Contact us at CTSOgroup@umich.edu

MBNI Building, 205 Zina Pitcher Place, Ann Arbor, MI 48105

A list of CTSO-CTSU contacts are available in the Personnel Directory.