Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials.

Sarzotti-Kelsoe, Marcella; Cox, Josephine; Cleland, Naana; Denny, Thomas; Hural, John; Needham, Leila; Ozaki, Daniel; Rodriguez-Chavez, Isaac R; Stevens, Gwynneth; Stiles, Timothy; Tarragona-Fiol, Tony; Simkins, Anita

doi:10.1371/journal.pmed.1000067

Type

Subject

Clinical Laboratory Techniques
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Humans
Practice Guidelines as Topic

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https://hdl.handle.net/10161/14736

Published Version (Please cite this version)

10.1371/journal.pmed.1000067

Publication Info

Sarzotti-Kelsoe, Marcella; Cox, Josephine; Cleland, Naana; Denny, Thomas; Hural, John; Needham, Leila; ... Simkins, Anita (2009). Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials. PLoS Med, 6(5). pp. e1000067. 10.1371/journal.pmed.1000067. Retrieved from https://hdl.handle.net/10161/14736.

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Scholars@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) and the Center for HIV/AIDS Vaccine Immunology (CHAVI), 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. He has recently been appointed to the Duke University Fuqua School of Business Health Sector Advisory Council. Previously, he was an Associate Professor of Pathology, Laboratory M

Marcella Sarzotti-Kelsoe

Research Professor of Immunology

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

Alphabetical list of authors with Scholars@Duke profiles.

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

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Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials.

Scholars@Duke

Thomas Norton Denny

Marcella Sarzotti-Kelsoe

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