Clinical Research Support Services for NIEHS Contract

该可分割任务订单的目的是为所有环境自身免疫组（EAG）临床研究提供全面的管理、临床和研究支持、统计、数据库和存储库管理以及监管协助。这包括：受试者筛选、评估和处置；按需要填写礼仪表格；安排和管理现场和校外招生流程；数据库的创建、融合和更新；数据清理和分析；样品的收集和储存、交付和处理；确保完成所有问卷调查，并根据任何SOP或其他变更以及卫生与人类服务部、国防部、食品和药物管理局、退伍军人事务部、任何其他监督机构和其他合作实体的规章制度所需的其他行政流程完成同意修订。

The purpose of this severable task order is to provide overall administrative, clinical and research support, statistical, database and repository management, and regulatory assistance for all Environmental Autoimmunity Group (EAG) clinical studies. This includes: subject screening, evaluation and disposition; completion of protocol forms as needed; arranging and managing onsite and offsite enrollment processes; database creation, fusion and updating; data cleaning and analyses; sample collection and storage, deliveries, and processing; ensuring completion of all questionnaires and consent revisions as needed per any SOP or other changes and other administrative processes needed per Health and Human Services, Department of Defense, Food and Drug Administration, Veteran’s Affairs, any other oversight agencies and other collaborating entities’ rules and regulations.