Clinical Translational Core

临床翻译（CT）核心解决了进行人类研究的研究者面临的挑战。 行为和生物行为研究IDD条件，如自闭症，脆性X综合征，唐氏症， 综合征参与者可能很难招募，因为他们在一般情况下的患病率相对较低 人口此外，一旦被招募，这些参与者需要由具有专业知识的专业人员进行评估。 培训以确认诊断并确定是否符合入选/排除标准。招募 通常，发展控制参与者也可能具有挑战性，特别是对于幼儿的研究， 需要生物采样或神经成像，因为父母通常不愿意登记。CT核心是 旨在帮助IDDRC调查人员克服这些挑战，提供服务，包括参与者 招募、社区外展、初步诊断资格、入选和排除标准评估， 并为这些活动分配人员和资源。CT核心工作人员和资源专门用于 这些活动将使现有的参与者队伍大大多样化;提高成本效益 通过在项目间共享参与者资格特征，提高效率和生产力;并提供 超出特定调查人员的专业知识或预算，但对最高级别的调查人员至关重要的资源。 质量行为和生物行为科学。个人和基础设施与拟议 在过去的十几年里，CT Core为MIND研究所的许多资助研究提供了类似的服务。 虽然这些服务的范围较为有限，而且以前没有整合成一个单一的 组织结构。拟议的合并和由联合国支助所提供的扩大 IDDRC U 54赠款（以及MIND研究所和加州大学戴维斯分校的额外机构支持）将 提高效率，降低服务成本，从而鼓励更多地使用IDDRC调查人员， 扩大诊断性评价服务，加强征聘工作，特别是在 招募不同种族、经济背景的参与者。 CT核心的主要目标是建立和维持一个最佳的业务框架 用于招募和诊断评估和表征各种特殊和典型的 人口数量。我们将通过以下具体目标实现这一目标： 1.通过系统的社区参与进程，加强对各种参与者的招募 参与，包括多个民族，种族和经济背景，包括非典型和典型 在很大的年龄跨度上发展。 2.维护参与者登记和跟踪系统，其中包括关键描述性信息， 允许研究者选择最有可能符合特定资格的参与者进行招募 的搜索. 3.提供经验丰富的评估人员，他们可以为诊断评估的最佳实践提供建议， 标准化措施的选择，提供标准化措施管理方面的培训， 可靠性和持续监测管理保真度，并进行专门的诊断评估， needed.

The Clinical Translational (CT) Core addresses the challenges facing investigators who conduct human behavioral and biobehavioral research on IDD conditions, such as autism, fragile X syndrome, and Down syndrome. Participants can be difficult to recruit because of their relatively low prevalence in the general population. Moreover, once recruited, these participants require evaluations by professionals with specialized training to confirm diagnoses and determine whether inclusion/exclusion criteria are met. Recruitment of typically developing control participants can also be challenging, particularly for studies of young children that require biologic sampling or neuroimaging because parents are often reluctant to enroll. The CT Core is designed to help IDDRC investigators overcome these challenges by providing services that include participant recruitment, community outreach, initial diagnostic qualification, assessment of inclusion and exclusion criteria, and allocation of personnel and resources for these activities. The CT Core staff and resources dedicated to these activities will significantly diversify the available pool of participants; improve cost effectiveness efficiency, and productivity by sharing participant qualification characteristics across projects; and provide resources that are beyond the expertise or budget of specific investigators but are essential to the highest quality behavioral and biobehavioral science. The individuals and infrastructure associated with the proposed CT Core have provided similar services to many funded studies at the MIND Institute over the last dozen years, although these services were more limited in scope and were not previously integrated into a single organizational structure. The integration proposed and the expansion afforded by the support of the IDDRC U54 grant (and the additional institutional support of the MIND Institute and UC Davis) will increase efficiency, lower costs of services thereby encouraging greater use by IDDRC investigators, expand diagnostic evaluation services, and increase recruitment efforts, especially as regards the recruitment of ethnically, racially, and economically diverse participants. The primary objective of the CT Core is to establish and maintain an operational framework that is optimal for recruitment and diagnostic assessment and characterization of a diverse range of special and typical populations. We will achieve this objective by addressing the following Specific Aims: 1. Enhance recruitment of a diverse range of participants through a systematic process of community engagement, including multiple ethnicities, races, and economic backgrounds with both atypical and typical development across a wide age span. 2. Maintain a participant registry and tracking system that includes critical descriptive information, permitting investigators to select participants for recruitment who are most likely to meet specific eligibility criteria. 3. Provide experienced evaluators who can advise studies in best practices for diagnostic assessment and standardized measure selection, provide training in administration of standardized measures, establish initial reliability and ongoing monitoring of administration fidelity, and conduct specialized diagnostic assessments as needed.