iTech - Analytic-Core

分析核心(AC)将为开展定性研究提供专门知识和系统， 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内部的互动以及与NICHD的互动。这项工作是跨部门组织的 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)、 分析和传播(目标3)每项研究活动的阶段，咨询委员会将负责任地和战略性地 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 完成。它由一个领导团队组成，由Eli Rosenberg博士和Kathryn Muessig博士共同指导，以及 三个子团队：随机对照试验(RCT)、成本分析和定性团队。 第一个目标是通过以下方式支持信息技术研究的质量、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。这个 定性团队将与研究项目PI合作，制定有效和一致的(研究之间)方案， 确保IRB的批准，并设计定性数据收集、存储和分析的系统。RCT团队 将实施基于网络的招聘筛选和计算机音频辅助面试工具，设计案例 报表和收集制度，制定和实施随机计划和制度，并实施 用于研究应用程序使用、实验室和保留数据的数据捕获和存储系统。成本分析 团队将与项目绩效指标一起开发成本输入参数和收集工具。第二个目标 通过收集和维护高质量的研究数据来支持协议实施 实时监控研究进度。对于所有研究活动，咨询委员会将向管理层提供数据 在积极注册期间每周监控应计费用，以确保每一项研究都能满足注册要求 在预计的时间范围内实现目标。RCT团队将定期汇总研究数据以监控所有关键 研究进展报告、数据质量报告和研究数据形式的区域工作队活动领域 报告。当NICHD为给定的RCT协议推荐时，AC将采取行动组装一个DSMB。这个 第三个目标是确保数据分析以最高科学标准进行，并确保结果 及时传播。除了支持信息技术研究和试点研究外，咨询委员会还将 与管理核心协作，确保项目和科目招聘地点(SRV) 达到了里程碑，数据标准得到维护，传播是及时的。与 技术核心将确保参与者的招募和保留以及自我收集的分析 测试样本。AC还将作为其他资助的U19提供技术援助的资源 基于技术的数据系统的测量和分析。

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.