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Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials

  • Marcella Sarzotti-Kelsoe mail,

    msarzott@duke.edu

    Affiliation: Duke University, Center for AIDS Research Central QA Unit, Durham, North Carolina, United States of America

    X
  • Josephine Cox equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: International AIDS Vaccine Initiative, Rockville, Maryland, United States of America

    X
  • Naana Cleland equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: Henry M. Jackson Foundation for the Advancement of Military Medicine–Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland, United States of America

    X
  • Thomas Denny equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: Duke Human Vaccine Institute, Center for HIV/AIDS Vaccine Immunology, Durham, North Carolina, United States of America

    X
  • John Hural equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: HIV Vaccine Trials Network, Seattle, Washington, United States of America

    X
  • Leila Needham equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliations: Duke University, Center for AIDS Research Central QA Unit, Durham, North Carolina, United States of America, Duke Human Vaccine Institute, Center for HIV/AIDS Vaccine Immunology, Durham, North Carolina, United States of America

    X
  • Daniel Ozaki equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: Duke University, Center for AIDS Research Central QA Unit, Durham, North Carolina, United States of America

    X
  • Isaac R. Rodriguez-Chavez equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland, United States of America

    Current address: AIDS and Immunosuppression Program, Integrative Biology and Infectious Diseases Branch, Division of Extramural Research, National Institute of Dental and Craniofacial Research, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland, United States of America.

    X
  • Gwynneth Stevens equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: International AIDS Vaccine Initiative, Johannesburg, Gauteng, South Africa

    X
  • Timothy Stiles equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: Qualogy Ltd, Kettering, United Kingdom

    X
  • Tony Tarragona-Fiol equal contributor,

    equal contributor Contributed equally to this work with: Josephine Cox, Naana Cleland, Thomas Denny, John Hural, Leila Needham, Daniel Ozaki, Isaac R. Rodriguez-Chavez, Gwynneth Stevens, Timothy Stiles, Tony Tarragona-Fiol

    Affiliation: International AIDS Vaccine Initiative Core Laboratory, Imperial College London, London, United Kingdom

    X
  • Anita Simkins

    Affiliation: AlphaVax Human Vaccines, Research Triangle Park, North Carolina, United States of America

    X
  • Published: May 05, 2009
  • DOI: 10.1371/journal.pmed.1000067

About the Authors

Marcella Sarzotti-Kelsoe, Leila Needham, Daniel Ozaki
Duke University, Center for AIDS Research Central QA Unit, Durham, North Carolina, United States of America
Josephine Cox
International AIDS Vaccine Initiative, Rockville, Maryland, United States of America
Naana Cleland
Henry M. Jackson Foundation for the Advancement of Military Medicine–Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland, United States of America
Thomas Denny, Leila Needham
Duke Human Vaccine Institute, Center for HIV/AIDS Vaccine Immunology, Durham, North Carolina, United States of America
John Hural
HIV Vaccine Trials Network, Seattle, Washington, United States of America
Isaac R. Rodriguez-Chavez
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland, United States of America
Gwynneth Stevens
International AIDS Vaccine Initiative, Johannesburg, Gauteng, South Africa
Timothy Stiles
Qualogy Ltd, Kettering, United Kingdom
Tony Tarragona-Fiol
International AIDS Vaccine Initiative Core Laboratory, Imperial College London, London, United Kingdom
Anita Simkins
AlphaVax Human Vaccines, Research Triangle Park, North Carolina, United States of America

Corresponding Author

Email: msarzott@duke.edu

Competing Interests

The authors have declared that no competing interests exist.

Author Contributions

ICMJE criteria for authorship read and met: MSK JC NC TD JH LN DO IRRC GS TS TTF AS. Wrote the first draft of the paper: MSK IRRC AS. Contributed to the writing of the paper: MSK JC NC TD JH LN DO IRRC GS TS TTF AS.