TASK ORDER 4R - ENVIRONMENTAL AUTOIMMUNITY GROUP (EAG) - STUDY SUPPORT

这项任务令的目的是提供全面的行政、临床和研究支持， 为所有环境自身免疫组(EAG)的临床研究提供统计、数据库和储存库管理以及监管协助。这包括：受试者筛选、评估和处置；根据需要填写方案表格；安排和管理现场和非现场登记过程；数据库创建、融合和更新；数据清理和分析；样本收集和存储、交付和处理；确保根据任何标准操作程序(SOP)或根据卫生与公众服务部、国防部、食品和药物管理局、退伍军人事务部、任何其他监督，根据需要完成所有问卷和同意修订 机构和其他合作实体的规章制度。 此任务订单将为EAG临床研究提供支持，其中服务可以分类 作为可分割和不可分割的，完成每项研究所需的执行期 和资金来源，可能会有所不同。因此，此任务订单，将合并 多个CLINS，以适当管理各种方案努力以及每个不同的业绩周期和资金来源。支持核心研究所需的努力将在CLIN1：EAG核心研究项下授予。其他相关工作可纳入本任务单中单独的CLINS项下。

The purpose of this 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 Standard Operating Procedure (SOP) or other changes and other administrative processes needed per Health and Human Services, De partment of Defense, Food and Drug Administration, Veteran’s Affairs, any other oversight agencies and other collaborating entities’ rules and regulations. This Task Order will provide support to the EAG clinical studies, where services can be classified as Severable and non-Severable, the performance period required for completion of each study and funding sources, may differ from one another. Therefore, this Task Order, will incorporate multiple CLINs to properly administer the various program efforts and each distinct performance period and funding sources. The efforts required to support the core studies will be awarded under CLIN1: EAG Core Studies. Additional related work may be incorporated to this Task Order under separate CLINs.