Core--Administration, Data Management, and Biostatistics

核心——行政、数据管理和生物统计学

• 批准号: 6997920
• 负责人: BART BARLOGIE
• 金额: $ 53.19万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-16 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6997920
• 关键词: biomedical facility; data management; multiple myeloma; statistics /biometry

The primary objective of this core, Administration, Data Management, and Biostatistics, is to support the Growth Control of Multiple Myeloma Program Project. All projects and cores of the P01 will require research and administrative coordination, management of patient-related data, and statistical analysis of data. Core A will encompass all of these services and provide them in a coordinated fashion so that all projects and cores contribute to a comprehensive approach, maximizing available resources. Provision of these services is fundamental to effective synergy among the basic, clinical, and translational studies that are the backbone of the Program Project. Core A's specific aims are as follows. Aim 1. Provide administrative support to all projects and cores, such that research activities are coordinated with appropriate interaction to accomplish goals of the overall P01. Administrative activities will include scheduling and management related to advisory meetings and regular meetings among investigators, coordination with the UAMS Office of Research and Sponsored Programs and Grants Accounting to ensure compliance with NIH guidelines and requirements, coordination with CRAB to ensure that data analysis needs are met, and coordination with the Data Management division of the Myeloma Institute to ensure accurate and timely collection of clinical trial data. Aim 2. Manage the overall data infrastructure. This includes maintaining the clinical database; electronic transfer of data over secure pathways; tracking samples and verifying that the necessary material is sent to the correct laboratory at the correct time; ensuring security and confidentiality of all data; and coordinating the assimilation of necessary data for analysis, including verifying eligibility, consenting patients to protocols, and ensuring protocol compliance. Aim 3. Provide biostatistical support to link study design, data collection, measurement, and analysis to the research hypotheses and questions under investigation in the P01. In the early stages, biostatisticians will work with investigators to define study hypotheses and populations and experimental parameters to answer the research questions of interest, reduce systematic bias, and ensure a high likelihood of detection of biologically meaningful effects. At the analysis stage, biostatisticians will identify and implement quantitative methods to address scientific questions of interest and provide valid statistical inferences about evidence supporting the various study hypotheses.

这个核心的主要目标，管理，数据管理和生物统计，是支持多发性骨髓瘤计划项目的生长控制。P01的所有项目和核心都需要研究和行政协调、患者相关数据的管理以及数据的统计分析。核心A将包括所有这些服务，并以协调的方式提供这些服务，以便所有项目和核心都有助于采取综合办法，最大限度地利用现有资源。提供这些服务是基础，临床和转化研究之间有效协同的基础，是该计划项目的骨干。核心A的具体目标如下。目标1.为所有项目和核心提供行政支持，以便研究活动与适当的互动协调， 总体目标P01。行政活动将包括与研究者之间的咨询会议和定期会议相关的日程安排和管理，与UAMS研究和赞助项目办公室和赠款会计协调以确保符合NIH指南和要求，与CRAB协调以确保满足数据分析需求，并与骨髓瘤研究所的数据管理部门协调，以确保准确和及时地收集临床试验数据。目标2.管理整个数据基础设施。这包括维护临床数据库;通过安全途径以电子方式传输数据;跟踪样本并核实必要的材料是否在正确的时间送到正确的实验室;确保所有数据的安全性和保密性;协调必要数据的同化以供分析，包括核实合格性、同意患者 并确保遵守协议。目标3.提供生物统计学支持，将研究设计、数据收集、测量和分析与P01中研究的研究假设和问题联系起来。在早期阶段，生物统计学家将与研究人员合作，定义研究假设和人群以及实验参数，以回答感兴趣的研究问题，减少系统偏倚，并确保检测到具有生物学意义的影响的可能性很高。在分析阶段，生物统计学家将确定和实施定量方法来解决感兴趣的科学问题，并提供有关支持各种研究假设的证据的有效统计推断。