DATA COORDINATING CENTER FOR VACCINE EVALUATION

疫苗评估数据协调中心

• 批准号: 6011771
• 负责人: Stephen J Durako
• 金额: $ 24.93万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-06-01 至 1999-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6011771
• 关键词: Streptococcus agalactiae; Streptococcus vaccine; antibacterial antibody; blood tests; cooperative study; data collection; human therapy evaluation; human tissue; information systems; microorganism culture; tissue resource /registry

The purpose of this contract is to obtain services to support a newly organized multicenter study entitled, "Determination of Protective Levels of Maternal Antibody Against Invasive Neonatal Group B Streptococcal Diseases." The study involves seven clinical centers in the U. S. which will assemble cases and controls subjects, and collect clinical and demographic data, maternal and cord blood specimens and Group B Streptococcus (GBS) organisms isolated from clinical specimens. In relation to this study, the Data Coordinating Center will participate in the establishment of protocol; manual of operations;data collection instruments; development and maintenance of computerized data entry, editing, and archiving for all demographic, clinical, and laboratory data; training of study personnel; and maintenance of a specimen collection, shipment, storage and retrieval, and development and maintenance of quality assurance procedures.

本合同的目的是获得服务以支持新的 组织了题为“保护水平的确定”的多中心研究 母体抗侵袭性新生儿 B 组链球菌抗体的研究 疾病。”该研究涉及美国七个临床中心，其中 将收集病例和对照受试者，并收集临床和 人口统计数据、母体和脐带血样本以及 B 组 从临床标本中分离出的链球菌 (GBS) 生物体。 在 与本研究相关，数据协调中心将参与 协议的建立；操作手册；数据收集 仪器；计算机化数据输入的开发和维护， 编辑和归档所有人口统计、临床和实验室数据； 研究人员的培训；和标本收集的维护， 运输、存储和检索以及开发和维护 质量保证程序。