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.

该核心，管理，数据管理和生物统计学的主要目标是支持多发性骨髓瘤计划项目的增长控制。 P01的所有项目和核心都需要研究和行政协调，与患者相关数据的管理以及数据的统计分析。核心A将涵盖所有这些服务，并以协调的方式提供它们，以便所有项目和核心有助于全面的方法，从而最大程度地提高可用资源。这些服务的提供对于该计划项目的基础研究的基础，临床和翻译研究中的有效协同作用至关重要。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，以便与适当互动协调研究活动以实现 整体P01的目标。 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。管理总体数据基础架构。这包括维护临床数据库；通过安全途径的数据传输；跟踪样品并验证必要的材料会在正确的时间发送到正确的实验室；确保所有数据的安全性和机密性；并协调所需数据进行分析的同化，包括验证资格，同意患者 进行协议，并确保协议合规性。 AIM 3。提供生物统计学支持，以将研究设计，数据收集，测量和分析与P01中研究的研究假设和问题相关。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，减少系统的偏见并确保发现生物学上有意义的效果的很有可能性。在分析阶段，生物统计学家将确定并实施定量方法，以解决有关感兴趣的科学问题，并提供有关支持各种研究假设的证据的有效统计推断。