Shared Resources Core

共享资源核心

• 批准号: 8936663
• 负责人: STEPHEN M HAHN
• 金额: $ 12.52万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8936663
• 关键词: Behavioral; Biological; Botswana; Characteristics; Clinical; Clinical Data; Clinical Research; Cohort Studies; Communication; Complex; Data; Data Collection; Demographic Survey; Developed Countries; Developing Countries; Discipline; Ensure; Environment; Epidemiology; Event; Funding; Funding Agency; Generations; Goals; Good Clinical Practice; HIV; Health Sciences; Human; Human Papillomavirus; International; Laboratories; Laboratory Study; Link; Malignant neoplasm of cervix uteri; Mentors; Monitor; Natural History; Patients; Population; Process; Public Health; Public Health Applications Research; Reporting; Research; Research Personnel; Research Project Grants; Resource Sharing; Resources; Sampling; Specimen; Time; Training; Translations; United States National Institutes of Health; Vulnerable Populations; Woman; Work; base; cohort; cost effective; data management; data sharing; design; evidence base; human data; improved; innovation; interdisciplinary approach; operation; patient population; population based; programs; prospective; research study; sample collection; tool

Centralized facilities and common processes have proven to improve the feasibility, efficiency and quality of complex studies or studies implemented within difficult environments. These centralized approaches permit more rapid translation of laboratory studies into clinical and public health applications. A major strength of this application is a truly multidisciplinary approach to better understand the entire spectrum of time-dependent events taking place natural history of HIV-associated cervical cancer in a very time- and cost-effective manner by leveraging the unique characteristics of three populations of patients. Our proposed strategy is highly innovative and unique but requires high level of coordination and harmonization of processes across disciplines, research projects and populations. Thus, the overall objective of this Core is to reconcile the needs and research approaches of all disciplines involved, in order to assure high-quality, uniform processes and tools for data and specimens collection. The Shared Resources Core will be directed by Drs Zetola (UPenn) and Chilisa (UB) who have a very extensive and successful track record designing and implementing large research studies of multiple designs in developed and developing countries, dealing with highly vulnerable populations and have received research funds from NIH and other international organizations. The SRC will be responsible for all field work, as well as data and human sample collection for this application. The core consists of staff, facilities and/or laboratories which are available to all investigators and proposed projects. These resources provide support for basic scientific research, clinical research and projects within the public health sciences. In specific, we: 1) We will design, implement and maintain the three prospective observational cohorts of Botswana women that will produce the data and specimens for this application's research projects. Each of these cohorts has unique features that will allow the study of early, intermediate and late events in the natural history of HPV-associated cervical cancer in HIV-infected women; 2) We will provide researches with a diverse array of biological specimens from subjects who are well characterized in terms of clinical, behavioural, and epidemiologic parameters. A central focus of this Core is managing and maintaining the entire spectrum of study-related human specimens; and, 3) Will coordinate data management and data sharing activities, as well as administrative and communication tasks. In addition, the SRC will assure compliance with Good Clinical Practices, establish standards for study coordination, and billing compliance. The shared Resources Core will serves as a link between the existing monitoring, training and mentoring programs and will provide an evidence-based approach to efficient use of both resources. We will gather and report up-to-date information on a real-time basis related to the research management of all projects. Routine, periodic reports will be provided not only to support the management of the daily CRS operations, but also many Cores proposed program as well as reporting to our stakeholders and funding agencies.

事实证明，集中式设施和共同流程可提高可行性，效率和质量 在困难环境中实施的复杂研究或研究。这些集中式方法允许更多 将实验室研究快速翻译成临床和公共卫生应用。这是一个主要优势 应用是一种真正的多学科方法，可以更好地了解整个时间依赖时间的事件 通过时间和成本效益的方式，以艾滋病毒相关的宫颈癌的自然历史 利用三个患者人群的独特特征。我们提出的策略是高度创新的 和独特，但需要高度的协调和跨学科的过程协调，研究 项目和人口。因此，该核心的总体目标是调和需求和研究 涉及的所有学科的方法，以确保高质量，统一的流程和数据的工具以及 标本集合。共享资源核心将由Zetola博士（Upenn）和Chilisa（UB）指导 拥有非常广泛而成功的往绩设计，并实施了多重研究的大型研究 发达国家和发展中国家的设计，处理高度脆弱的人口并已收到 来自NIH和其他国际组织的研究资金。 SRC将负责所有现场工作， 以及此应用程序的数据和人类样本收集。核心包括员工，设施和/或 所有调查人员和拟议项目都可以使用的实验室。这些资源为支持 公共卫生科学中的基础科学研究，临床研究和项目。具体而言，我们：1）我们将 设计，实施和维护博茨瓦纳妇女的三个前瞻性观察人群 该应用程序研究项目的数据和标本。这些队列中的每一个都有独特的功能 将允许研究与HPV相关的宫颈癌自然史上的早期，中间事件和晚期事件 在艾滋病毒感染的妇女中； 2）我们将为研究提供各种生物标本的研究 他们在临床，行为和流行病学参数方面具有很好的特征。这是一个重点 核心正在管理和维护整个与研究相关的人类标本的整个范围。 3）将协调 数据管理和数据共享活动以及行政和通信任务。另外， SRC将确保遵守良好的临床实践，建立研究协调标准和计费 遵守。共享资源核心将作为现有监视，培训和 指导计划，并将提供基于证据的方法来有效利用这两种资源。我们将 与所有项目的研究管理有关的实时收集并报告最新信息。 日常工作，定期报告将不仅用于支持每日CRS操作的管理，还会提供 还有许多核心计划以及向我们的利益相关者和资助机构报告。