Research Sponsors

Office of Clinical Research Overview

An important goal of the Office of Clinical Research is to establish mutually productive relationships with industry by understanding the Sponsor's priorities and goals, meeting timelines, and providing an efficient contract process to facilitate timely execution of sponsor agreements. The OCR believes working in concert with industry will result in more clinical trial opportunities for University of Chicago faculty, access to the latest drugs and medical devices for our patients, increased patient access to novel therapies and more opportunities for collaboration in the beginning stages of product development.

Questions

Why place studies at the University of Chicago?
How can I locate an investigator?

What types of studies are being conducted at the University of Chicago?
How does the University of Chicago define a clinical trial?
Where do I find The University of Chicago sponsored contract template?
Master Clinical Trial Agreements
What is the cost structure at the University of Chicago?
What is a Clinical Research Support Office (CRSO)?
What is University Research Administration (URA)?

What is the University of Chicago's Federal Wide Assurance (FWA) number?

What is the BSD/UCH Institutional Review Board (BSD/UCH IRB)?
What clinical trial registration language should be included in contracts?
What is the OCR?

Why place studies at the University of Chicago?

The OCR provides Sponsors with access to one of the nation's premier medical and research centers, a large and diverse patient population, a portal to investigators and an experienced, dedicated and qualified staff as a point of contact responsive to industry needs.

The University of Chicago is committed to the following:

  • Providing patients access to innovative and cutting edge diagnostics and therapies
  • Establishing, developing and maintaining productive, cooperative relationships with sponsors of clinical trials
  • Maintaining compliance with federal, state and local regulations protecting the rights and welfare of all research participants

The University of Chicago Medical Center expertise:

  • The only Illinois hospital listed in US News & World Report's Honor Roll 2005
  • Extensive experience successfully conducting industry sponsored studies
  • Over 400 investigators involved in clinical research
  • 400 clinical research support staff (Nurses, CRA's and Project Managers/Coordinators)
  • Regional, national and international expertise in may diseases, conditions and disorders
  • Efficient and timely review of protocol and contract

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How can I locate an investigator?

Over 400 regionally, nationally and internationally recognized physicians are participating in clinical research at the University of Chicago. Many of the faculty have extensive experience conducting trials and are interested in partnering with Industry sponsors on important protocols. If you are interested in placing a study at the University of Chicago, or need assistance completing feasibility surveys for potential study placement please contact the investigator directly or the Office of Clinical Research.

Bethany Martell, Director, Office of Clinical Research, at 773-834-9799.

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What types of studies are being conducted at the University of Chicago?

The University of Chicago and the University of Chicago Medical Center, are committed to advancing biomedical innovation and furthering the knowledge of healthcare professionals. This commitment is practiced everyday, as the University of Chicago and the University of Chicago Medical Center perform more clinical trials than any other hospital in Illinois. Our research helps healthcare professionals around the country--and around the world--to better treat many diseases, conditions and disorders. Plus, it gives our patients access to new diagnostic techniques, treatments and therapies. Our physicians have expertise conducting studies through the spectrum of drug and device development including; Phase I, II and III studies under Investigational New Drug Criteria, and Device Studies under Investigational Device Exemptions.

Clinical expertise can be found in the following departments:

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How does the University of Chicago define a clinical trial?

A clinical trial is operationally defined as a prospective study involving human subjects that is designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions. Such studies may include drugs, treatments, devices, or behavioral/ nutritional strategies.

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Where do I find The University of Chicago sponsored contract template?

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What is the cost structure at the University of Chicago?

Study Initiation/Start-Up Fees (if applicable)

  • Institutional Review Board (IRB) - $3,000 ($3,750 with indirect cost)
  • Principal Investigator review of study-sliding scale
  • Coordinator review of study-sliding scale
  • Regulatory Preparation Fee/CRSO (if applicable) (link to definition of a CRSO)
  • Pharmacy/Investigational Drug Service Fee - $800 per protocol + per patient fees starting at $150 under (if applicable)

Indirect Cost Rates

  • 25% Non-Federally Funded Clinical Trials
  • 40% Non-Clinical Trial Studies
  • 56% Federally-Funded

Clinical Care Expenses

  • Varies by service

Study Implementation and Oversight Expenses

  • Staff time (including, but not limited to: completing CRF's, AE/SAE monitoring and reporting, subject management, triage, follow up, training and education)
  • Supplies
  • Parking stickers
  • Long term record storage
  • Shipping costs
  • Other

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What are the Clinical Research Support Offices (CRSO)?

The mission of the CRSO is to promote and facilitate the conduct of clinical research within individual departments. It is a centralized resource that supports established programs within the departments as well as new programs. The CRSOs consist of Regulatory Affairs Managers as well as experienced Clinical Research Nurses and Clinical Research Associates that are available to assist investigators in all aspects of conducting clinical and translational research. In 1998, under the directive of the chairman of the Department of Medicine, the first CRSO was formed in order to support investigators and expand clinical research programs. The successes and practices from the first CRSO have been expanded and now are in place in multiple clinical departments. The CRSO can assist in the expansion of research programs by providing centralized support services for our faculty in addition to serving as a centralized resource to industry sponsors. The following list illustrates benefits of centralization:

  • Greater efficiency through reduction in duplicate efforts and more timely processes
  • Rapid response and flexibility
  • Single point of contact
  • Customer Service
  • Expertise in process
  • Compliance through training and educational programs

For more information please call Bethany Martell, Director, Office of Clinical Research, at 773-834-9799.

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What is University Research Administration (URA)?

University Research Administration (URA) provides review and institutional endorsement of all applications for sponsored funding including Clinical Studies/Trials and Material Transfer Agreements. URA also reviews and negotiates contract terms (when necessary,) prior to acceptance of awards officially on behalf of the University.

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What is the University of Chicago's Federal Wide Assurance (FWA) number?

Through an agreement with the U.S. Department of Health and Human Services, The University of Chicago assures that all research involving human subjects conducted at The University of Chicago - by University faculty, students, or staff - will be conducted in accordance with the ethical principles spelled out in the Belmont Report. Our FWA agreement covers all federally funded research ensuring that the University is in compliance with all federal regulations and policies through extensive review. The University has chosen as matter of institutional policy to extend such review to non-federally-funded research. This agreement is called a Federal Wide Assurance. The University of Chicago's Federal Wide Assurance of Compliance (FWA) with DHHS Regulations for Protection of Human Research Subjects can be found here.

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What is the Biological Sciences Division/University of Chicago Hospitals/Pritzer School of Medicine Institutional Review Board (IRB)?

The BSD/Hospitals IRB handles all biomedical and behavioral research within the Biological Sciences Division and the University of Chicago Medical Center. The IRB is charged with the responsibility for review, approval and surveillance of all research involving human subjects carried out in the BSD and the University of Chicago Medical Center. This review and surveillance is conducted to assure the protection of the rights and welfare of all research subjects, including volunteers and patients.

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What clinical trial registration language should be included in contracts?

The International Committee of Medical Journal Editors (ICJME) has stated that they "will consider a trial for publication only if it has been registered before the enrollment of the first patient". For pharmaceutically sponsored studies, it is the primary responsibility of the trial sponsor to register the study. The following language must be included in pharmaceutically-sponsored contracts.

Required language:

"SPONSOR will take such actions as necessary to qualify the results of the Study for publication by UC and/or INVESTIGATOR, including without limitation, by complying with the requirements of the International Committee of Medical Journal Editors and other applicable laws and regulations, including any applicable requirements and conditions for publication of the Food and Drug Administration pertaining to the pre-initiation registration of the Study. Company shall provide proof of such registration to the Institution."

Contact: Adaora Ogbuefi in the Office of Clinical Research at 773-702-3240 or aogbuefi@bsd.uchicago.edu for questions regarding clinical trial registration.

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What is the OCR?

The Office of Clinical Research (OCR) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific infrastructure components related to clinical and translational research. In 2005, the OCR replaced the Clinical Trials Office and was a direct result of institutional support and dedication of resources from both the BSD and UCMC to support the infrastructure needed for clinical research. By providing high level guidance in the process of clinical/translational research conduct, the OCR seeks to enhance the excellence, scope and efficiency of these research efforts by facilitating and integrating activities already in place and by fostering clinical and translational research activities in areas where they are not yet fully developed. The OCR focuses on five key areas of service including:

  • Training and Education
  • Regulatory and Contract Oversight
  • Financial Management
  • Institutional Infrastructure
  • Human Subject Protection (IRB)

The OCR can assist sponsors with the following:

  • Identification of investigators
  • Coordination of timely response to site feasibility questionnaires
  • Obtaining information about general research operations, including institutional experience and capabilities
  • Regulatory preparation for external audits, including FDA

The OCR plays a key role in coordinating and collaborating with many of the departments to ensure that Regulatory and Clinical Support services are provided to investigators in an efficient, timely and compliant manor.

For more information please call Bethany Martell, Director, Office of Clinical Research, at 773-834-9799.

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