Abstract

The long-term objectives of this project continue to be the facilitation of high quality clinical research and compliance with federal and local regulations. In addition, we will partner with M.D. Anderson Cancer Center - Orlando, a community based regional center just beginning a new cancer research program to extend the benefits of our advances in human subjects protection. 1. The mandatory faculty-training course has been designed and implemented. We will continue to offer it to new faculty and fellows. We will develop new modules to update all faculty on regulatory chanl;es (e.g., HIPAA and conflict-of-interest policy changes). 2. Complete an integrated process to allow comparison of information in the conflict-of-interest (COI) database developed under the previous award with both the clinical research database (Protocol Data Management System, PDMS) which contains the names of all principal and coinvestigators on human subject research protocols and the protocol authoring data base (Protocol Document On-Line System, PDOL) which contains the informed consent documents. 3. Implement the next critical phase of the Clinical Oncology Research (CORe) Oracle-based system, the electronic continuing review process. 4. Create a new functionality in the PDOL system that will allow the attachment of various word processing file types to any protocol document, thus allowing protocols that are received from outside the institution to be incorporated into the protocol database. 5. Partner with M.D. Anderson Cancer Center - Orlando (MDACC-Orlando) in the development of their clinical research program by training MDACC-Orlando investigators, research nurses, and data managers using our training program and providing Orlando access to registration on clinical trials over the world wide web via the PDMS system and access to all our IRB standard operating procedures.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Biomedical Research Support Grants (S07)
Project #
2S07RR018240-02
Application #
6777167
Study Section
Special Emphasis Panel (ZRR1-RI-A (01))
Program Officer
Beck, Lawrence A
Project Start
2002-09-01
Project End
2004-08-31
Budget Start
2003-09-01
Budget End
2004-08-31
Support Year
2
Fiscal Year
2003
Total Cost
$250,000
Indirect Cost

  Institution

Name
University of Texas MD Anderson Cancer Center
Department
Internal Medicine/Medicine
Type
Other Domestic Higher Education
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030