Clinical Core

CTNA临床核心作为各种临床项目和试点的中心资源发挥着重要作用。它代表了酒精研究中心相对于一组个人赠款的明显优势。有机会为一个有杰出领导人的中央设施提供资金，为确定需求和分配资源以解决中心问题提供了一种方案方法。临床核心的核心组成部分是监督所有临床项目的受试者招募和临床评估、数据管理和分析。这一核心的具体目标是： A.集中监测受试者招募，以：1）提高每个项目（包括试点项目）的入组效率; 2）向主要研究者（PI）、科学顾问委员会和数据安全监测委员会更新方案进展情况 B。对评估进行集中监督，以：1）提高培训和评估的效率; 2）保持评估管理的一致性; 3）提高研究者汇总研究数据的能力; 4）确保使用经验证的最新评估工具; 5）支持利用核心评估进行二次分析。 C.集中提供数据管理和生物统计支持，以：1）提供设计和分析专业知识，以满足CTNA科学议程的目标; 2）提供最先进的数据管理方法; 3）生成随机化列表并评估随机化实施情况; 4）与CTNA相关特定技术（包括遗传学和成像）相关的专业数据分析专业知识进行交流; 5）为数据安全监查委员会准备与临床研究进展相关的报告; 6）为所有研究者提供统计支持。

The CTNA Clinical Core serves an important function as the central resource for the diverse clinical projects and pilots. It represents the distinct advantage of an Alcohol Research Center over a cluster of individual grants. The opportunity to fund a central facility with a distinguished leader provides a programmatic method to define needs and assign resources to address central issues. The central components of the Clinical Core are oversight of subject recruitment and clinical assessments for all clinical projects, data management and analysis. The specific aims for this core are: A. Centralized monitoring of subject recruitment to: 1) Enhance the efficiency of enrollment into each project, including pilots; and 2) Update the Principal Investigators (PIs), the Scientific Advisory Board, and the Data Safety Monitoring Board of progress on the protocols B. Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data across studies; 4) Insure that validated and current assessment tools are used; and 5) Support secondary analyses utilizing core assessments. C. Central provision of Data Management and Biostatistics support to: 1) Provide design and analytical expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-art methods for data management; 3) Generate randomization lists and assess randomization implementation; 4) Interface with specialized data analysis expertise related to particular technologies associated with the CTNA, including genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data Safety Monitoring Board; and 6) Provide statistical support for all investigators.