Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL)
Abstract
The EQAPOL contract was awarded to Duke University to develop and manage global proficiency
testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine
analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to
be made available to National Institutes of Health (NIH) researchers. As a part of
this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices
(GCLP) that are traditionally used for laboratories conducting endpoint assays for
human clinical trials. EQAPOL adapted these guidelines to the management of proficiency
testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which
are specifically designed for external proficiency management. Over the first two
years of the contract, the EQAPOL Oversight Laboratories received training, developed
standard operating procedures and quality management practices, implemented strict
quality control procedures for equipment, reagents, and documentation, and received
audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL,
strengthen a laboratory's ability to perform critical assays and provide quality assessments
of future potential vaccines. © 2013 The Authors.
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https://hdl.handle.net/10161/14709Published Version (Please cite this version)
10.1016/j.jim.2013.09.012Publication Info
Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; & Sarzotti-Kelsoe,
Marcella (2014). Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External
Quality Assurance Program Oversight Laboratory (EQAPOL). Journal of Immunological Methods, 409. pp. 91-98. 10.1016/j.jim.2013.09.012. Retrieved from https://hdl.handle.net/10161/14709.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Thomas Norton Denny
Professor in Medicine
Thomas N. Denny, MSc, M.Phil, is the Chief Operating Officer of the Duke Human Vaccine
Institute (DHVI), Associate Dean for Duke Research and Discovery @RTP, and a Professor
of Medicine in the Department of Medicine at Duke University Medical Center. He is
also an Affiliate Member of the Duke Global Health Institute. Previously, he served
on the Health Sector Advisory Council of the Duke University Fuquay School of Business.
Prior to joining Duke, he was an Associate Professor of Pathology, Labo
Marcella Sarzotti-Kelsoe
Research Professor of Integrative Immunobiology
Ongoing Applied Activities •I direct a Global Quality Assurance Program, which
I developed and pioneered here at Duke University, to oversee compliance with Good
Clinical Laboratory Practice Guidelines in three HIV vaccine trial networks (CHAVI,
CAVD, Duke HVTN, EQAPOL, Duke VTEU) involving domestic and international laboratory
sites. •I also direct a Global Proficiency Testing Program for laboratories testing
for neutralizing antibody function in individuals infected
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