Establishing a Pregnancy Lyme Disease Biobank

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Abstract
Availability of relevant biological samples supports both basic science research and patient-centered clinical studies. Establishing a biorepository faces challenges at multiple levels. These tasks include defining mission definition and scope; selection of subjects and sample types; recruitment strategies; timing of collection in the patient’s journey; sample logistics and processing; determining what clinical data to collect; ensuring sample integrity on transport, processing, and storage; defining governance structures and oversight responsibilities; clarifying sample provenance and ownership; establishing procedures for sample and data access; selecting testing to be performed routinely versus upon request, and management of results; data security; funding sources; and regulatory compliance. Establishing and maintaining a biorepository therefore requires careful planning, diligent and sustained execution, technical and financial resources, stakeholder support, and flexible and resilient management to respond to changing environments and needs. Key words Biobank Biospecimen Pregnancy Neonatal Fetus Processing Compliance Human subjects Data bank Outcomes

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