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

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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.