Concepedia

On-site Source Data Verification

On-Site Source Data Verification is a methodological process within clinical research monitoring wherein original source data are prospectively examined at the investigative site to confirm their accuracy, completeness, and consistency with recorded trial data, distinguished by its direct, physical access to source documents and real-time validation at the data origin.

11

Publications

456

Citations

61

Authors

33

Institutions

Publications per year

2017–2026

1

Variants

On-site Sdv

Parents

Publications

11

Field validation of listings of food stores and commercial physical activity establishments from secondary data

Catherine Paquet, Mark Daniel, Yan Kestens et al. · International Journal of Behavioral Nutrition and Physical Activity · 2008 · 108 citations · Full text

, , +13

Application of methods for central statistical monitoring in clinical trials

Amy A. Kirkwood, Trevor F. Cox, Allan Hackshaw · Clinical Trials · 2013 · 78 citations · Full text

, , +16

Impact of source data verification on data quality in clinical trials: an empirical <i>post hoc</i> analysis of three phase 3 randomized clinical trials

J.R. Andersen, I. Byrjalsen, Asger Reinstrup Bihlet et al. · British Journal of Clinical Pharmacology · 2014 · 49 citations · Full text

, , +17

Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials

Nicole Sheetz, Brett Wilson, Joanne Benedict et al. · Therapeutic Innovation & Regulatory Science · 2014 · 48 citations · Full text

, , +16

Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection

Anne S. Lindblad, Zorayr Manukyan, Tejashri Purohit-Sheth et al. · Clinical Trials · 2013 · 46 citations

, , +16

1–5 of 11

Authors

61

  1. BJ
    Bente Juel Riis

    University of Copenhagen, Denmark

    1 publications · 49 citations

    1

    h-index

  2. RS
    Rinn-Sup Shinn

    1 publications · 14 citations

    1

    h-index

  3. JA
    James A. MacMahon

    Utah State University, United States

    1 publications · 14 citations

    1

    h-index

  4. AM
    Ann Meeker-O’Connell

    Johnson & Johnson (United States), United States

    1 publications · 46 citations

    1

    h-index

  5. KL
    Karine Léger

    Université de Montréal, Canada

    1 publications · 108 citations

    1

    h-index

1–5 of 61

Institutions

33

  1. Vanderbilt University Medical Center

    Nashville, United States

    1 h-index

    1 publications

    33 citations

  2. Allergan (Ireland)

    Westport, Ireland

    1 h-index

    1 publications

    48 citations

  3. Universidade do Estado do Rio de Janeiro

    Rio de Janeiro, Brazil

    1 h-index

    1 publications

    12 citations

  4. Medidata (United States)

    New York, United States

    1 h-index

    2 publications

    96 citations

  5. University of Copenhagen

    Copenhagen, Denmark

    1 h-index

    1 publications

    49 citations

  6. Bristol-Myers Squibb (Sweden)

    Solna, Sweden

    1 h-index

    2 publications

    96 citations

  7. Michigan United

    Kalamazoo, United States

    1 h-index

    1 publications

    33 citations

  8. Boehringer Ingelheim (South Korea)

    Seoul, South Korea

    1 h-index

    1 publications

    48 citations

1–8 of 33

Venues

  1. Clinical Trials

    3 publications · 142 citations

    3

    h-index

  2. Perspectives in Clinical Research

    1 publications · 22 citations

    1

    h-index

  3. Redalyc (Universidad Autónoma del Estado de México)

    Repository · 1 publications · 12 citations

    1

    h-index

  4. 1

    h-index

  5. PLoS ONE

    1 publications · 33 citations

    1

    h-index

1–5