DATA COORDINATING CENTER FOR VACCINE EVALUATION

本合同的目的是获得服务，以支持新的 有组织的多中心研究，题为“保护水平的确定” 新生儿侵袭性B群链球菌母源抗体的研究 这项研究涉及美国的七个临床中心， 将收集病例和对照对象，并收集临床和 人口学数据、母血和脐带血样本以及B组 从临床标本中分离的链球菌(GBS)。在……里面 关于这项研究，数据协调中心将参与 协议的制定；操作手册；数据收集 仪器.计算机化数据输入的开发和维护 对所有人口统计、临床和实验室数据进行编辑和归档； 培训研究人员；维护标本收集， 运输、储存和检索以及开发和维护 质量保证程序。

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.