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Clinical Research Support Services for NIEHS Contract

NIEHS 合同临床研究支持服务

基本信息

批准号：
9369088
负责人：
DAVID WAGNER
金额：
$ 50.78万
依托单位：
SOCIAL AND SCIENTIFIC SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-06-18 至 2017-06-17
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9369088
关键词：
Adverse event Advertising Autoantibodies Autoimmune Process Autoimmunity Biopsy Specimen Calcinosis Clinical Clinical Research Collaborations Conflict of Interest Connective Tissue Diseases Consent Contractor Contracts Data Data Analyses Data Reporting Databases Department of Defense Dermatomyositis Development Diagnosis Enrollment Ensure Environmental Risk Factor Evaluation Health Hobbies Human Institutional Review Boards Laboratories Ligase Military Personnel Monitor Myositis National Institute of Environmental Health Sciences Natural History Nursing Research Occupations Pathogenesis Patients Physicians Process Protocols documentation Questionnaires Regulation Reporting Research Assistant Research Support Sampling Services Signs and Symptoms Site Spottings Study Subject Surveys Syndrome Test Result Time Treatment Protocols Twin Multiple Birth United States Food and Drug Administration United States National Institutes of Health Update Veterans Visit demographics material transfer agreement patient subsets repository response rituximab sample collection screening sodium thiosulfate

项目摘要

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.

这一可分离的任务命令的目的是为环境自身免疫组(EAG)的所有临床研究提供全面的行政、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；根据需要完成方案表格；安排和管理现场和非现场登记流程；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、任何其他监督机构和其他协作实体的规章制度所需的其他行政流程完成所有问卷和同意修订。