DATA COORDINATING CENTER FOR VACCINE EVALUATION

点击翻译按钮获取中文摘要

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.