IMMUNOLOGY QUALITY ASSESSMENT (IQA) PROGRAM

Duke University, Durham NC

Investigators

Abstract

Central to NIAID scientific priorities is the need to support the conduct of clinical studies for the prevention and treatment of HIV/AIDS and its infectious and non-infectious co-morbidities, domestically and internationally. The purpose of this contract is to provide a resource to evaluate and enhance the ability of U.S. and non-U.S. laboratories (Labs) to participate in NIAID-funded and collaborative clinical studies by: (1) monitoring the ability of Labs to reliably perform study-specified immunological tests and cryopreserve peripheral blood mononuclear cells (PBMCs) and other human biological samples; (2) facilitating the optimization, standardization and validation of immunological assay methodologies, with focus on laboratory-developed-tests (LDTs) for implementation in NIAID-supported studies; (3) helping Labs meet sponsor and regulatory requirements for good clinical laboratory practices (GCLP) and submission of data to regulatory agencies; and (4) hosting and maintaining an electronic data management system and document library in support of contract activities. are also within the scope of the contract.