Data Coordination and Analyses Center for the Community and Child Health Network

社区和儿童健康网络数据协调和分析中心

• 批准号: 8291644
• 负责人: Vernon M Chinchilli
• 金额: $ 49.51万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-28 至 2012-12-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8291644
• 关键词: Address; Area; Asthma; Biological; Blood; Certification; Child; Child health care; Childhood; Childhood Asthma; Clinical Research; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Cohort Studies; Collaborations; Communication; Communities; Community Health Centers; Computer Assisted; Data; Data Collection; Data Coordinating Center; Data Quality; Databases; Detection; Documentation; Education; Effectiveness; Ensure; Evaluation; Faculty; Funding; Funding Agency; General Population; Genetic; Health; Health Insurance Portability and Accountability Act; Health Professional; Human Development; Infant; Information Dissemination; Information Networks; Institutes; Institution; Intention; Internet; Interview; Label; Laboratories; Leadership; Link; Lung diseases; Manuals; Measures; Medicine; Monitor; Mothers; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Office of Administrative Management; Online Systems; Outcome; Participant; Pediatric Research; Pennsylvania; Performance; Perinatal; Phase; Placenta; Population Research; Pregnancy; Pregnancy Outcome; Prevention; Principal Investigator; Procedures; Process; Protocols documentation; Publications; Recruitment Activity; Regulation; Reporting; Research; Research Infrastructure; Research Institute; Research Personnel; Resources; Saliva; Sampling; Science; Secure; Shipping; Ships; Site; Site Visit; Specimen; Statistical Models; Surveys; System; Time; TimeLine; Training; U-Series Cooperative Agreements; Universities; Update; Validation; Writing; authority; base; behavioral/social science; clinical research site; college; computer network; computerized data processing; data exchange; data integrity; data management; demographics; design; distributed data; experience; meetings; member; operation; programs; protocol violation; quality assurance; repository; social; symposium; tool; web site; wide area network

DESCRIPTION (provided by applicant): The National Institute of Child Health and Human Development (NICHD) announced its intention (RFA- HD-06-001) to establish a Data Coordination and Analyses Center (DCAC) for the Community and Child Health Network (CCHN). The CCHN will comprise a cooperative agreement among the NICHD, three-to-five Clinical Research Sites (CRSs), and one DCAC. The CCHN will have a Steering Committee (SC) and a Data and Safety Monitoring Board (DSMB). Phase I of the CCHN is near completion and Phase II will consist of a cohort study with 4,000-5,000 participants in the perinatal period who will be followed until their next pregnancies. The CCHN will screen and recruit participants, measure social and biological indicators, and assess outcome variables in the mothers and infants. The Department of Health Evaluation Sciences (DHES) at The Pennsylvania State University College of Medicine proposes to serve as the DCAC for the CCHN. The DCAC will pursue five specific aims to enhance the effectiveness of the CCHN: (1) provide statistical leadership and scientific coordination in the areas of trial design, conduct, analysis, presentations, and publications; (2) establish and maintain the CCHN computer network and websites, one for the general public and a password-protected, secure site for CCHN members; (3) design and maintain the CCHN data management system that relies on a web-based system; coordinate and track CCHN biological specimens; (4) develop and maintain the CCHN data quality assurance and monitoring program to ensure the highest quality data possible; (5) provide project management and administrative support to render smooth and efficient operations in the CCHN. Dr. Chinchilli, the proposed Principal Investigator (principal investigator) of the CCHN DCAC, has extensive experience as the principal investigator of two data coordinating centers (DCCs) for clinical research networks funded by the National Heart, Lung, and Blood Institute (NHLBI), namely, the Asthma Clinical Research Network and the Childhood Asthma Research and Education Network. Because DHES has successfully pioneered many approaches for DCC activities in a clinical research network, the NHLBI Division of Lung Diseases enlisted DHES to train the awardees of the DCCs for two other clinical research networks that it recently formed. Dr. Chinchilli's Co- Investigators for the DCAC include faculty members with additional experience in pediatric statistical issues (Dr. Shaffer), statistical modeling of social and behavioral sciences data (Dr. Rovine), statistical genetics (Dr. Liu), pediatric research (Dr. Paul), adverse pregnancy outcomes (Dr. Weisman), and disparities in children's health (Dr. Hillemeier). In addition, the Penn State Survey Research Center and the Population Research Institute will provide expertise on computer-assisted personal interviewing and geocoding data, respectively.

描述（由申请人提供）：国家儿童健康与人类发展研究所（NICHD）宣布其意图（RFA-HD-06-001），以建立社区和儿童健康网络（CCHN）的数据协调和分析中心（DCAC）。 CCHN将在NICHD，三到五个临床研究地点（CRS）和一个DCAC之间构成合作协议。 CCHN将有一个指导委员会（SC）和数据和安全监控委员会（DSMB）。 CCHN的第一阶段即将完成，第二阶段将包括一项队列研究，与4,000-5,000名参与者在围产期的参与者进行，直到下一次怀孕。 CCHN将筛选和招募参与者，衡量社会和生物学指标，并评估母亲和婴儿的结果变量。宾夕法尼亚州立大学医学院的卫生评估科学系（DHES）建议作为CCHN的DCAC。 DCAC将追求五个特定的目标，以提高CCHN的有效性：（1）在试验设计，行为，分析，演示和出版物领域提供统计领导和科学协调； （2）建立和维护CCHN计算机网络和网站，一个用于公众，一个由密码保护的CCHN成员的安全网站； （3）设计和维护依赖基于Web的系统的CCHN数据管理系统；协调和跟踪CCHN生物标本； （4）制定和维护CCHN数据质量保证和监视计划，以确保可能的最高质量数据； （5）提供项目管理和行政支持，以在CCHN中渲染流畅有效的操作。 CCHN DCAC的首席研究员（主要研究人员）Chinchilli博士拥有由国家心脏，肺部和血液研究所（NHLBI）资助的两个数据协调中心（DCCS）的主要研究者，即ASTHMA临床研究网络和儿童研究网络和教育。由于DHES在临床研究网络中成功开创了许多DCC活动的方法，因此NHLBI肺部疾病司令DHES邀请DHES培训DCC的获奖者，以供其最近形成的其他两个临床研究网络。 Chinchilli博士的DCAC共同研究人员包括在儿科统计问题（Shaffer博士），社会和行为科学数据（Rovine博士），统计遗传学（LIU博士），儿科研究（Paul）（Paul），不良妊娠孕期（Weisman）（Weisman）和迪斯特（Disement）的儿童（Health）（Health）的统计模型（Rovine），统计遗传学（LIU）和儿童的健康（Hilly）。此外，宾夕法尼亚州调查研究中心和人口研究所将分别提供有关计算机辅助的个人访谈和地理编码数据的专业知识。