Clinical Assessment Core

临床评估核心

• 批准号: 10005488
• 负责人: Celine Antoinette Saulnier
• 金额: $ 46.03万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-04 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005488
• 关键词: Abbreviations; Achievement; Adaptive Behaviors; Address; Adherence; Age; Behavior; Biological; Biological Models; Birth; Caring; Certification; Child; Child health care; Childhood; Clinical; Clinical Research; Clinical assessments; Collaborations; Collection; Communication; Communities; Data; Data Analyses; Data Collection; Development; Diagnostic; Eligibility Determination; Ensure; Environment; Ethics; Evaluation; Extended Family; Family; Family member; Feedback; Genetic; Goals; Human; Human Resources; Infant; Infant Care; Interview; Journals; Letters; Maintenance; Marketing; Measures; Medical Genetics; Online Systems; Outcome Assessment; Parents; Participant; Pediatrics; Procedures; Process; Protocols documentation; Psychologist; Quality Control; Radio; Recommendation; Reproducibility; Research; Research Personnel; Resources; Risk; Sampling; Services; Shapes; Siblings; Speech Pathologist; Standardization; Time; Training; Treatment outcome; United States National Institutes of Health; Universities; Work; autism diagnostic observation schedule; autism spectrum disorder; autistic children; brain behavior; clinical care; clinical diagnostics; cohort; data management; expectation; high risk; instrument; medical schools; meetings; outreach; pediatric department; procollagen Type I N-terminal peptide; programs; recruit; satisfaction; social; symposium; transmission process

PROJECT SUMMARY The overall objectives of the Emory ACE Assessment Core (AC) are to provide Projects I, II, III & IV with the following: I a: Recruitment: to ensure that a sufficient number of subjects are recruited for P-I – P-IV in an efficient and ethical manner, with efforts to reduce attrition and maximize follow-through, making full use of the vast clinical resources available through MAC, CHOA, and our numerous community relationships, specifically with primary pediatric and OB/GYN practices (see LOSs #1-3 and R&E S.7.2.1, S.8.7, S.9.4.2); I b: Clinical Characterization: to provide P-I – P-IV with a well centralized, supported, and coordinated assessment protocol to ensure the accurate collection and management of diagnostic, assessment, and genetic data from birth through age 30 months at the following time points: 6, 12, 16, 21, and 30 months; I c: Clinical Care: to provide optimal clinical care to the 250 infants and their families, including supports associated with children’s risk and/or developmental status throughout their longitudinal participation; I d: Training & Reliability: to ensure achievement of high-level procedural and numerical reliability among the CAC clinicians, maintenance of achieved reliability, and correction of drift among staff; and I e: Quality Control: to ensure investigator satisfaction and quality control of procedures by implementing continuous and efficient communication between investigators and the CAC, data and regulatory audits, and adherence to Scientific Rigor & Reproducibility in every aspect of data collection, safeguarding independence between risk-treatment-outcome status, and between clinical/experimental procedures.

项目概要 埃默里大学 ACE 评估核心 (AC) 的总体目标是为项目 I、II、III 和 IV 提供 I a：招募：确保在 P-I – P-IV 中招募足够数量的受试者 以高效和道德的方式，努力减少人员流失并最大限度地提高后续行动，充分利用 通过 MAC、CHOA 和我们众多的社区关系可获得大量临床资源，特别是 具有主要儿科和妇产科实践（参见 LOS #1-3 和 R&E S.7.2.1、S.8.7、S.9.4.2：临床）； 表征：为 P-I – P-IV 提供良好集中、支持和协调的评估协议 确保从出生起准确收集和管理诊断、评估和遗传数据 30 个月大时的以下时间点：6、12、16、21 和 30 个月 Ic：临床护理：提供； 为 250 名婴儿及其家人提供最佳的临床护理，包括与儿童风险和/或相关的支持 整个纵向参与过程中的发展状况 I d：培训和可靠性：确保 在 CAC 精英中实现高水平的程序和数值可靠性，维护 实现可靠性，并纠正工作人员之间的偏差；以及 I e：质量控制：以确保研究者 通过实施持续有效的沟通来提高程序的满意度和质量控制 调查员和 CAC、数据和监管审计，以及遵守科学严谨性和可重复性 数据收集的各个方面，维护风险-治疗-结果状态之间的独立性，以及 临床/实验程序之间。