Clinical Research Support Services for NIEHS Contract Task Order 4 - Environmental Autoimmunity Group

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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.