Core Directors: Veena B. Antony, M.D.

RS31823 Veena Antony 3

The overall objective of the Clinical Core 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 projects 1-4.