The overall objective of the Clinical Core (Core B) is to provide the personnel, state of the art facilities and organizational structure necessary to recruit human subjects, generate a research database, procure and store human biological specimens for the four proposed projects in Cycle 2 of the UAB tPPG. The previous Cycle of the tPPG has informed and expanded the function of proposed Clinical Core. In the three years (at the time of this writing) over a hundred subjects have been recruited into the studies, new data and investigators recruited into related research and the hypotheses for the present projects validated with preliminary data.
The specific aims of Cycle 2 Clinical Core are the following:
Specific Aim 1 : Manage the identification, recruitment, informed consent process, and enrollment of patients Projects 1-4 Specific activities will include: (a) Obtain approval from the UAB Institutional Review Board for Human Use (IRB) (b) Identify eligible subjects in collaboration with the Project Investigators (c) Obtain informed consent in collaboration with Project Investigators.
Specific Aim 2 : Manage clinical data collection, and biological specimen collection and distribution. Specific activities will include: (a) Enter subject's demographic and clinical data into a research database (b) Coordinate with Core A to provide demographic and clinical data to individual projects for statistical analysis (c) Coordinate procurement, and distribution of biological specimens to projects 1, 2, 3, and 4 (d) Continue implementation of a quality control process for specimen handling, transfer, storage and data management. All projects will utilize the Clinical Core. The Clinical Core will function as the central hub of sample and data procurement to accelerate discoveries by projects1-4.

Public Health Relevance

The Clinical Core will serve as the central hub for patient recruitment sample and data procurement to assist and synergize experimental plans as proposed in Projects 1-4. All Projects will utilize the services provided by the Clinical Core. In Cycle 1 of the tPPG we have collected specimens from over a hundred subjects, refined standard operating procedures and over forty publications have emanated from the tPPG by year three as of this writing. The Clinical Core is made of a team of clinicians (pathologists, radiologists, pulmonologists) and scientists, who meet regularly to adjudicate diagnoses, perform quality assurance and review data to provide state of the art Clinical Core service to the Projects.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Program Projects (P01)
Project #
2P01HL114470-06
Application #
9356777
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Craig, Matt
Project Start
Project End
Budget Start
2018-08-01
Budget End
2019-07-31
Support Year
6
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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