Office of Clinical Research: FAQs

What is the difference between the OCR, CRSO, URA, IRB?

Research is full of many acronyms which can be confusing. Here is a breakdown of abbreviations used at UCMC (University of Chicago Medical Center) and the BSD (Biological Sciences Division of the University of Chicago)

The Office of Clinical Research (OCR) is a single point of contact for any protocol involving human subjects in the University of Chicago Medical Center. The OCR oversees educational programs, auditing, clinical research billing, and reviews all new protocols, contracts, informed consent documents for harmonization.

The Clinical Research Support Office (CRSO) provides research support for the department of medicine, including: research nurses, budget writing, IRB submissions and regulatory support.

University Research Administration (URA) provides review and institutional endorsement of all applications for sponsored funding including clinical studies/trials and Material Transfer Agreements; URA reviews, and negotiates when necessary, awards prior to acceptance, and accepts awards officially on behalf of the University. URA maintains a program of sponsored project information services and data for University faculty and administrators. URA is the ONLY authorized signature for contracts, and confidentiality agreements.

Institutional Review Board (IRB) 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. The IRB must approve all protocols, informed consent forms and amendments before they can be implemented. IRB also has mandate for reporting serious and unexpected adverse events and major protocol deviations.

OCR Office of Clinical Research http://clinicalresearch.bsd.uchicago.edu/
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 Hospitals by providing a single point of contact for investigators and sponsors who wish to conduct clinical research studies at the University of Chicago. By providing high level guidance to investigators and staff in the conduct of clinical research, the OCR seeks to enhance the excellence, scope, and efficiency of these research efforts by facilitating and integrating all required regulatory steps and by fostering clinical research activities throughout the institution. The OCR focuses on four key areas including:

Training and Education
Regulatory Affairs
Contracting and Financial Management
Quality Assurance

The office is committed to working in collaboration with investigators, research staff and administrators from all departments to establish interdepartmental trust, collaborations, joint efforts, and alliances with other units in the University and Hospitals.

CRSO Clinical Research Support Office http://medicine.uchicago.edu/crso.htm
The mission of the Clinical Research Support Office is to promote and facilitate the conduct of clinical research in the Department of Medicine. The Department of Medicine has a long tradition of conducting original and rigorous biomedical and clinical research that has dramatically affected the way in which diseases are treated. The CRSO was created to assist in the expansion of this remarkable research record by providing centralized support services for our faculty as well as serving as a centralized resource for industry sponsors.
The Clinical Research Support Office (CRSO) provides patients with access to state of the art therapies and drugs, supports investigators in the range of services necessary to plan and conduct clinical trials, and gives industry sponsors access to our skilled investigators, our experienced study coordinators, and our active and involved patient population.
For more information contact:
Allison Buonamici
Director, Clinical Research Support Office
Phone: 773-834-3330
Email: abuonami@medicine.bsd.uchicago.edu

Mailing Address:
Clinical Research Support Office
Department of Medicine
5841 S. Maryland Avenue (MC 6091)
Chicago, Illinois 60637
Phone: 773-834-3708
Fax: 773-834-4172

URA University Research Administration http://researchadmin.uchicago.edu/
Overview of URA Mission: URA provides review and institutional endorsement of all applications for sponsored funding including clinical studies/trials and Material Transfer Agreements; URA reviews, and negotiates when necessary, awards prior to acceptance, and accepts awards officially on behalf of the University. URA maintains a program of sponsored project information services and data for University faculty and administrators. See Proposal Submission & Award Acceptance and Authorized Signature.

URA reports to the Deputy Provost for Research. Its two sections are under the direction of the Associate Vice President for Research and Director of University Research Administration. These sections are: (1) Grants and Contracts Management and (2) Information Services. URA now has merged with the former ORS Office of Research Services from the BSD.

URA Services - Grants and Contracts Management

Grants and contracts managers review each proposal to the federal, state, and local governments, foundations, corporations, and associations prior to submission. They verify the accuracy of budget and administrative information provided in applications; ensure that commitments made in proposals can be honored; and confirm that proposals and awards meet sponsor and University guidelines. They work directly with faculty members and University administrators in this process. URA is the authorized institutional signatory for all proposals and awards.
URA grants and contracts managers negotiate grants and contracts on behalf of the University; assist in the preparation of requests for additional funding, extensions in time, and changes in scope or principal investigator; coordinate the submission of interim project reports; and coordinate all steps needed to terminate an award.
URA is the authorized institutional signatory for all Material Transfer Agreements (MTAs). Sharing of materials such as cell lines, transgenic animals, and human/animal tissues are handled through MTAs. URA negotiates and executes MTAs on behalf of University faculty and staff.
URA is authorized negotiator and signatory for clinical studies. Faculty are urged to consult with the Office of Clinical Research for additional assistance with company-sponsored trials.

URA Services - Information Services

Assisting faculty members in identifying potential sources of federal and nonfederal sponsored support using the Illinois Researcher Information System (IRIS), the World Wide Web, and other resources;
Maintaining the URA Web site; and
Maintaining TRACS, an administrative database which tracks information about proposals submitted and awards made to the University of Chicago.

URA conducts a series of training courses on grants and contracts management and identifying potential sources of sponsored funds.
URA is located on the third floor of the University's bookstore building, 970 East 58th Street. Our main phone number is (773) 702-8669. Our fax number is (773) 702-2142. Feel free to call us or to come by the office.

IRB Institutional Review Board http://bsdirb.bsd.uchicago.edu/
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.

Federal regulations require an Institutional Review Board (IRB) to review research on human subjects if the research involves federal funding. The Biological Sciences Division of the University of Chicago has determined that all research undertaken at this institution under its jurisdiction, or by those persons affiliated with this institution, must undergo the same level of review as research that falls under federal regulations. The University has obtained a Federalwide Assurance (FWA), which signifies that the University and the University of Chicago Hospitals are in compliance with the Federal requirements for the protection of human subjects for federally-funded research. For details on the University's FWA, please visit the University Research Administration's.

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URA Services - Information Services

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