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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

基本信息

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
项目类别：
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

项目摘要

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.

该任务令的目的是提供全面的行政、临床和研究支持，