CORE C: HUMAN SUBJECTS CORE

核心 C：人类受试者核心

基本信息

批准号：
10399997
负责人：
Karla McGregor
金额：
$ 52.46万
依托单位：
FATHER FLANAGAN'S BOYS' HOME
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-15 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10399997
关键词：
Address Adolescent Affect Budgets Centers of Research Excellence Cerebral Palsy Child Clinical Clinical assessments Collaborations Communication Communities Consent Consultations Data Data Collection Databases Development Effectiveness Enrollment Ensure Evaluation Fee-for-Service Plans Fees Foundations Funding Goals Grant Health Fairs Individual Infant Institutional Review Boards Laboratories Laboratory Study Language Development Disorders Language Disorders Measurement Measures Minority Groups Minority Participation Monitor Participant Perception Periodicity Phase Preparation Procedures Process Productivity Progress Reports Protocols documentation Quality Control Regulation Reporting Research Research Personnel Resources Review Committee Sample Size School-Age Population Scientist Services Special Population Standardization System Testing Time Training Trust United States National Institutes of Health Update base data sharing design evidence base hearing impairment human subject innovation interest member minority children minority communities programs quality assurance recruit study population sustainable resource

项目摘要

PROJECT SUMMARY/ABSTRACT CORE C: HUMAN SUBJECTS CORE The Human Subjects Core (HSC) is designed to support investigators in clinical measurement, recruitment, and compliance through centralization of services and expertise. Research programs that involve human subjects encounter challenges related to standardized testing, recruitment of special populations, and regulatory compliance. Time, effort, and resources are required to overcome these barriers, and individual investigators and their laboratories rarely have the capacity to address them without consequences to productivity. The HSC addresses these challenges through two integrated programs (1) a Clinical Measurement Program (CMP), and (2) a Recruitment and Quality Assurance Program (RQP). These programs are designed to provide investigators access to clinical experts, recruitment support, data sharing, and staff supports in compliance and quality monitoring. These centralized supports have led to increased efficiency, collaboration, and productivity in the research program during Phase I. In Phase II, we plan to continue these effective programs while also expanding our efforts by recruiting and testing children with developmental language disorders, by updating and integrating our databases, and by implementing plans that will increase the financial self-sufficiency of the HSC over time.

项目摘要/摘要核心C：人类对象核心人类受试者核心（HSC）旨在支持研究人员进行临床测量，招聘，和通过集中服务和专业知识的合规性。涉及人类的研究计划受试者遇到与标准化测试，特殊人群招募以及的挑战法规合规性。需要时间，精力和资源来克服这些障碍和个人调查人员及其实验室很少有能力在没有后果的情况下解决这些问题生产率。 HSC通过两个集成程序解决这些挑战（1）临床测量计划（CMP）和（2）招聘和质量保证计划（RQP）。这些程序旨在为调查人员提供临床专家的访问权限，招聘支持，数据共享和员工支持合规性和质量监控。这些集中的支持导致效率提高，合作，以及第一阶段的研究计划中的生产力。在第二阶段，我们计划继续这些有效的计划，同时还通过招募和测试发育中的儿童来扩大我们的努力语言障碍，通过更新和集成我们的数据库以及实施将增加的计划随着时间的流逝，HSC的财务自给自足。