iTech - Analytic-Core

iTech - 分析核心

• 批准号: 9505773
• 负责人: Kathryn E Muessig
• 金额: $ 74.05万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9505773
• 关键词: Case Report Form; Collaborations; Collection; Computers; Consult; Consultations; Continuity of Patient Care; Cost Analysis; Data; Data Analyses; Data Collection; Data Quality; Data Reporting; Development; Economics; Enrollment; Ensure; Fostering; Funding; Information Dissemination; Information Systems; Institutional Review Boards; Interview; Laboratories; Leadership; Maintenance; Measurement; Monitor; National Institute of Child Health and Human Development; Online Systems; Patient Recruitments; Phase; Pilot Projects; Prevention; Procedures; Progress Reports; Protocols documentation; Randomized; Randomized Controlled Trials; Reporting; Research; Research Activity; Research Design; Research Project Grants; Resources; Secure; Specimen; System; Technology; Testing; Time; Work; base; collaborative environment; cost; design; innovative technologies; meetings; participant retention; programs; real time monitoring; recruit; research study; tool

The Analytic Core (AC) will provide expertise and systems for the conduct of qualitative studies, randomized controlled trials (RCT), and economic studies to support the aims of the iTech and its research and pilot studies, interactions within the ATN, and with NICHD. This work is organized across three aims that follow the research project lifecycle. Throughout the development (Aim 1), execution (Aim 2), analysis, and dissemination (Aim 3) phases of each study activity, the AC will responsibly and strategically manage its resources to foster a collaborative environment, maintain scientific rigor, and ensure timely work completion.It is composed of a Leadership Team, co-directed by Drs. Eli Rosenberg and Kathryn Muessig, and three subteams: the Randomized Controlled Trial (RCT), Cost Analysis, and Qualitative Teams. The first aim supports the development of iTech studies' qualitative, RCT, and costing activities by consulting on valid study design and establishing best-practice data collection systems and procedures. The Qualitative Team will work with research project PIs to develop valid and consistent (between-study) protocols, secure IRB approval, and design systems for qualitative data collection, storage, and analysis. The RCT Team will implement web-based recruitment screener and computer audio-assisted interview tools, design case report forms and collection system, develop and implement randomization plans and systems, and implement data capture and storage systems for study app usage, laboratory, and retention data. The Cost Analysis Team will work with project PIs to develop cost input parameters and collection tools. The second aim supports protocol implementation through the collection and maintenance of high-quality study data and real-time monitoring of study progress. For all research activities, the AC will provide data to the Management Core to monitor accrual on a weekly basis during active enrollment, to ensure each study is meeting enrollment targets within estimated timeframes. The RCT Team will routinely summarize study data to monitor all key domains of RCT activities, in the form of study progress reports, data quality reports, and research data reports. When recommended by NICHD for a given RCT protocol, the AC will act to assemble a DSMB. The third aim is to ensure that data analyses are conducted to the highest scientific standards and that results are dissemination in a timely way. In addition to supporting the iTech research and pilots studies, the AC will work collaboratively with the Management Core to ensure project and subject recruitment venue (SRV) milestones are met, data standards are upheld and dissemination is timely. Collaboration with the Technology Core will serve to ensure participant Recruitment and Retention and analysis of self-collected testing specimens. The AC will also serve as a resource to other funded U19s providing technical assistance on measurement and analysis of technology-based data systems.

分析核心（AC）将提供进行定性研究的专业知识和系统， 随机对照试验（RCT）和经济研究，以支持iTech及其 研究和试点研究，ATN内部以及与NICHD的互动。这项工作是跨组织的 遵循研究项目生命周期的三个目标。在整个开发（目标1），执行（目标2）， 在每项研究活动的分析和传播（目标3）阶段，咨询委员会将负责任地、战略性地 管理其资源，以促进协作环境，保持科学严谨性，并确保及时工作 它由一个领导小组组成，由Eli Rosenberg博士和Kathryn Muessig博士共同领导， 三个小组：随机对照试验（RCT）、成本分析和定性小组。 第一个目标是通过以下方式支持iTech研究的定性、RCT和成本计算活动的发展 就有效的研究设计提供咨询，并建立最佳实践数据收集系统和程序。的 定性团队将与研究项目PI合作，制定有效且一致的（研究间）方案， 确保IRB批准，并设计定性数据收集、存储和分析系统。RCT团队 将采用基于网络的招聘筛选程序和计算机音频辅助面试工具，设计案例 报告表格和收集系统，制定和实施随机化计划和系统，并实施 用于研究应用程序使用、实验室和保留数据的数据采集和存储系统。成本分析 团队将与项目PI合作开发成本输入参数和收集工具。第二个目的 通过收集和维护高质量研究数据支持方案实施， 实时监测研究进展。对于所有研究活动，AC将向管理层提供数据 核心人员在主动入组期间每周监测一次招募，以确保每项研究符合入组要求 在预计的时间范围内。RCT团队将定期总结研究数据，以监测所有关键 RCT活动的领域，以研究进展报告、数据质量报告和研究数据的形式 报道当NICHD推荐给定RCT方案时，AC将负责组建DSMB。的 第三个目标是确保按照最高科学标准进行数据分析， 及时传播。除了支持iTech研究和试点研究外，AC还将 与管理核心协作，确保项目和受试者招募地点（SRV） 达到里程碑，数据标准得到维护，传播及时。协同 技术核心将用于确保参与者的招募和保留以及自我收集的分析 测试样本。咨询委员会还将为其他获得资助的U19提供技术援助 测量和分析基于技术的数据系统。