(Clinical Research Core) The overall objective of the Clinical Research Core is to build and expand a comprehensive, effective, and sustainable clinical and community-based research infrastructure which will promote and facilitate the conduct of clinical, translational, and implementation research in cardiometabolic diseases at Tulane University. The core will provide support in the design, conduct, and analysis of clinical research to the COBRE junior faculty investigators and other clinical investigators.
The specific aims of this facility are: 1. to advise and assist the COBRE junior faculty investigators in study design, including sample size calculations and power analysis; 2. to help the COBRE junior faculty investigators in study protocol development and IRB submission; 3. to provide clinical research space, equipment, and other resources for the COBRE junior faculty investigators and other COBRE investigators to implement their individual research projects; 4. to facilitate study participant recruitment; 5. to provide trained and certified clinical research staff for clinical visits, data collection, and intervention; 6. to provide clinical and biochemical laboratory support for the collection, processing, and analysis of bio-specimens; 7. to provide bio-specimen storage in a hurricane-protected freezer farm facility; 8. to support community-based studies and implementation research projects; 9. to establish a stringent quality assurance and quality control program for clinical and laboratory data collection; 10. to provide consulting on biostatistical issues and data entry, data management, statistical analysis, and data interpretation services to the COBRE junior faculty investigators and other COBRE investigators; 11. to provide the above services to non-COBRE investigators on a discounted fee-for-service basis; and 12. to develop a business plan for long- term sustainable operation of the Clinical Research Core, including prioritization of service requests, assistance in research grant preparation, participation in NIH or non-NIH supported multicenter clinical trials, and providing clinical research services to the scientific community at large for a fee. The Clinical Research Core is critically important for the proposed COBRE program, the junior investigators, and their individual research projects. Four of the proposed individual research projects will utilize the clinical research space, clinical equipment, biochemical laboratory and staff, and all five individual research projects will use the statistical consulting services. The core will play a central role in assisting junior factor investigators with their research projects and their transition into successful competitive independent investigators. The core will also play an important role in establishing and maintaining an internationally recognized clinical, translational, and implementation research program in the etiology, prevention, and treatment of cardiometabolic diseases at Tulane University.

Public Health Relevance

(Clinical Research Core) The Clinical Research Core will provide support in the design, conduct, and analysis of clinical research to the COBRE junior faculty investigators, other COBRE investigators, and the clinical research community at large across schools within Tulane University. It will play an important role in establishing and maintaining an internationally recognized clinical, translational, and implementation research program in the etiology, prevention, and treatment of cardiometabolic diseases at Tulane University.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Exploratory Grants (P20)
Project #
5P20GM109036-02
Application #
9241411
Study Section
Special Emphasis Panel (ZGM1-TWD-6)
Project Start
Project End
Budget Start
2017-03-01
Budget End
2018-02-28
Support Year
2
Fiscal Year
2017
Total Cost
$576,108
Indirect Cost
$193,312
Name
Tulane University
Department
Type
Domestic Higher Education
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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