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

任务顺序 4R - 环境自身免疫组 (EAG) - 研究支持

• 批准号: 10630801
• 负责人: NASTARAN BAYAT
• 金额: $ 19.87万
• 依托单位: SOCIAL AND SCIENTIFIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10630801
• 关键词: Accountability; Adverse event; Advertising; Amendment; Autoantibodies; Autoimmunity; Award; Back; Biological; Biological Specimen Banks; Biopsy; Blood; Clinical; Clinical Laboratory Information Systems; Clinical Research; Clinical Services; Clinical Trials Database; Clinical assessments; Collaborations; Collection; Conflict of Interest; Consent; Consent Forms; Contractor; DNA; Data; Data Analyses; Data Collection; Data Reporting; Databases; Development; Diagnosis; Enrollment; Ensure; Environmental Risk Factor; Equipment and supply inventories; Evaluation; Experimental Pathology; Fractionation; Funding Agency; Health; Hobbies; Human; Image; International; Laboratories; Ligase; Monitor; Myositis; National Institute of Environmental Health Sciences; Nursing Research; Occupations; Outcome; Parents; Participant; Patients; Performance; Periodicity; Peripheral Blood Mononuclear Cell; Physicians; Plasma; Procedures; Process; Protocols documentation; Questionnaires; RNA; Records; Regulation; Reporting; Research; Research Assistant; Research Personnel; Research Support; Research Training; Sampling; Serum; Services; Ships; Signs and Symptoms; Site; Specimen; Spottings; Surveys; Syndrome; Test Result; Time; Tissues; United States Department of Veterans Affairs; United States Food and Drug Administration; United States National Institutes of Health; Update; Visit; Whole Blood; Work; data cleaning; demographics; interest; material transfer agreement; member; patient screening; patient subsets; performance site; programs; recruit; repository; research study; response; sample collection; screening

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.

本任务订单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）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、评价和处置;根据需要填写方案表格;安排和管理现场和非现场入组流程;数据库创建、融合和更新;数据清理和分析;样本采集和储存、交付和处理;确保按照任何标准操作规程（SOP）完成所有调查问卷和知情同意书修订或卫生与公众服务部、国防部、食品和药物管理局、退伍军人事务部、任何其他监督部门所需的其他变更和其他行政程序 机构和其他合作实体的规则和条例。 本任务指令将为EAG临床研究提供支持，其中服务可分类 作为可分割和不可分割，完成每项研究所需的履约期 和资金来源，可能彼此不同。因此，本任务指令将纳入 多个项目经理，以正确管理各种计划工作和每个不同的绩效期和资金来源。支持核心研究所需的努力将在EAG核心研究下获得奖励。其他相关工作可根据单独的任务指令并入本任务指令。