Strategic Partners & Resources

The Clinical Trials Support Office has partnerships with various campus enterprises with deep expertise to better serve our study team’s needs. These resources 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 information to strengthen your clinical research and increase your career development. 

RESOURCES

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. 

MiChart Research Resources
A knowledgebase 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

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. 

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.