Clinical Core

摘要 临床核心（核心B）的总体目标是提供人员、最先进的设施和 招募人类受试者所需的组织结构，生成研究数据库，采购和存储 为UAB tPPG第2周期的四个拟议项目提供人体生物标本。 tPPG的上一个周期已告知并扩展了拟定临床核心的功能。在 三年来（在撰写本文时），已有100多名受试者被招募到研究中，新数据显示， 和调查人员招募到相关的研究和假设，目前的项目验证与 初步数据。第2周期临床核心的具体目标如下：具体目标1：管理 确定、招募、知情同意过程和患者入组 将包括：（a）获得UAB人用机构审查委员会（IRB）的批准（B） 与项目研究者合作，获得合格受试者的知情同意书（c）与 项目调查员。具体目标2：管理临床数据采集、生物样本采集和 分布具体活动将包括：（a）将受试者的人口统计和临床数据输入研究 数据库（B）与核心A协调，为各个项目提供人口统计学和临床数据， （c）协调生物标本的采购，并将其分发给项目1、2、3和 4（d）继续执行标本处理、转移、储存和数据的质量控制程序 管理所有项目都将使用临床核心。临床核心将作为以下方面的中心枢纽： 样品和数据采购，以加快项目的发现1 -4。

ABSTRACT 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.