Longitudinal Studies of HIV-Associated Lung Infections and Complications - DCC

描述(由申请人提供)： 这项拟议的研究名为艾滋病毒相关肺部感染和并发症的纵向研究(LSHLI)，计划是一项为期五年的多中心合作研究。国家心肺血液研究所(NHLBI)将与四到六个临床站点(CS)和一个数据协调中心(DCC)签约，以执行LSHLI方案。在这项作为这项研究的DCC的建议中，C-TASC的工作人员介绍了他们经过时间考验的方法如何应用于LSHLI，这些方法用于执行许多由NIH资助的类似研究。我们专注于我们在管理、协调、计算机服务和统计咨询领域的专业知识。这些服务已经被开发并成功地用于为NIH进行临床试验和观察性研究。作为这项研究的DCC，C-TASC的工作人员将负责监督程序开发的方案和手册，参与研究文件和程序的开发和维护，开发和实施基于Web的临床试验管理系统(CTMS)，对研究进行质量保证监测，协助研究人员进行分析计划的统计设计，执行统计分析，支持标本库活动，促进数据和标本的共享，安排研究会议和电话会议，并向NHLBI提供干净和完整的数据文件。C-TASC正在结束一项针对国家过敏症和传染病研究所(NIAID)的大型研究，这些工作人员将可以在LSHLI工作。我们与NHLBI和NIAID合作的悠久历史确保了拟议的工作人员拥有必要的知识来收集、分析和解释本研究将产生的高度专业化的数据。LSHLI的一个关键功能是将为几个较小的协议收集数据。这是C-TASC在妇女和婴儿传播研究(WITS)和肺组织研究联盟(LTRC)中熟悉的一种研究形式。C-TASC的工作人员已经制定了与LSHLI议定书和其他两项研究的程序手册中所要求的章节类似的章节。同样，表格、跟踪程序、审查程序、数据库编程和统计分析技术在这两项研究中得到了广泛发展，可以很容易地适应LSHLI。 如果C-TASC获得这一奖项，我们期待着担任LSHLI的DCC。

DESCRIPTION (provided by applicant): The proposed study, Longitudinal Studies of HIV-Associated Lung Infections and Complications (LSHLI), is planned to be a five-year multicenter, cooperative study. Four to six Clinical Sites (CS) and a Data Coordinating Center (DCC) will be contracted by the National Heart, Lung, and Blood Institute (NHLBI) to carryout the LSHLI Protocol. In this proposal to function as the DCC of this study, C-TASC staff present how their time- tested methods, used to carry out numerous similar NIH-funded studies, can be applied to the LSHLI. We focus on our expertise in the areas of administration, coordination, computer services, and statistical consulting. These services have been developed and used successfully to conduct clinical trials and observational studies for the NIH. As the DCC for this study, C-TASC staff will be responsible for providing oversight of Protocols and Manuals of Procedures development, participating in the development and maintenance of the study documents and procedures, developing and implementing a Web-based Clinical Trials Management System (CTMS), quality assurance monitoring of the study, assisting investigators in the statistical design of analysis plans, performing statistical analyses, supporting specimen banking activities, facilitating the sharing of data and specimens, arranging study meetings and conference calls, and providing the NHLBI with clean and complete data files. C-TASC is in the process of closing a large study for the National Institutes of Allergy and Infectious Diseases (NIAID) and these staff will be available to work in the LSHLI. Our long history of working with the NHLBI and NIAID ensures that the proposed staff have the requisite knowledge to collect, analyze and interpret the highly specialized data that will be generated in this study. A key feature of the LSHLI is that data will be collected for several smaller protocols. This is a study format familiar to C-TASC in the Women and Infants Transmission Study (WITS) and the Lung Tissue Research Consortium (LTRC). C-TASC staff have already developed similar chapters to the ones that will be required in the LSHLI Protocols and Manuals of Procedures in these two other studies. Likewise, forms, tracking procedures, review procedures, database programming, and statistical analysis techniques have been extensively developed in these two studies and can be easily adapted to the LSHLI. We look forward to serving as the DCC for the LSHLI should C-TASC receive this award.