|
Currently Enrolling Trials • Staff • Committees & Workgroups • Contact Information
WELCOME to the Office of Clinical Research Website
The Office of Clinical Research was established on July 1, 2007 to enhance, foster, and promote high-quality industry sponsored clinical research - the effective and efficient evaluation of new pharmaceuticals and medical devices - within the research community of the University of Tennessee Health Care System by providing a full spectrum of administrative services. The Office of Clinical Research works to ensure that clinical trials are conducted in a compliant, lawful and ethical way that benefits study participants, investigators, employees, and institution. We also serve investigators and staff by working as a liaison for industries looking to place studies.
Our services include study placement, study feasibility assessment, IRB and regulatory guidance, comprehensive contract and budget negotiation, and training initiatives to assure expert study coordination.
Currently, the services of the Office of Clinical Research are available to investigators affiliated with UT Medical Group, Inc. UTMG is a nonprofit, group medical practice of the faculty physicians of the College of Medicine at The University of Tennessee Health Science Center. Over time, investigators and research personnel in the other Departments and Colleges affiliated with the University of Tennessee Health Care System will have the opportunity to utilize the services of the Office of Clinical Research when conducing industry sponsored clinical research.
Raising the Bar for Clinical Research
Upcoming Events
Symposium on Scientific Integrity and Preventing Research Misconduct
Date: December 4, 2008
Time: 8:00 AM - 2:30 PM
Location: Freeman Auditorium 3rd Floor—930 Madison (Hamilton Eye Institute)
Speakers: Greg Koski, M.D. . Ph.D. and Cynthia Ricard, Ph.D.
Registration available on-line at
http://www.utmem.edu/research/research_administration/Seminar/seminar_reg.php
News
New Glossary
The U.S. Department of Health & Human Services Agency for Healthcare Research and Quality offers an important new reference tool (web-based glossary) posted for researchers, consumers, clinicians, insurers and others seeking information about the burgeoning science of comparative effectiveness.
Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Good Clinical Practice Program, HF-34
U.S. Department of Health and Human Services - Food and Drug Administration
Office of Science & Health Coordination, Office of the Commissioner
Draft Guidance - FDA 1572 - Statement of Investigator
Title: Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs - Frequently Asked Questions - Statement of Investigator FDA-1572
Draft Guidance - Study Subjects
Guidance for Industry Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators - May 2007
This draft guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The draft guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.
To Conduct or not to Conduct? That is the Question! UTMG OCR is the ANSWER
An article by Laura Cummins and Alisa Firehock
|
|
|
