Concepedia

Risk-based Source Data Verification

Risk-Based Source Data Verification is a systematic approach to verifying clinical trial data in which the extent and focus of source data checks are prioritized and tailored according to the level of risk to patient safety and data integrity, distinguishing it from comprehensive or random verification methods by its reliance on proactive risk assessment and targeted monitoring strategies.

9

Publications

256

Citations

57

Authors

28

Institutions

Publications per year

2017–2026

2

Variants

Risk-based Sdv

Parents

Publications

9

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

Validation of the Minimum Data Set in Identifying Hospitalization Events and Payment Source

Shubing Cai, Dana B. Mukamel, Peter J. Veazie et al. · Journal of the American Medical Directors Association · 2010 · 40 citations

, , +15

Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

Vadim Tantsyura, Imogene Dunn, Kaye Fendt et al. · Therapeutic Innovation & Regulatory Science · 2015 · 35 citations

, , +16

Risk-Based Monitoring in Clinical Trials: Past, Present, and Future

Brian J. Barnes, Nicole Stansbury, Debby Brown et al. · Therapeutic Innovation & Regulatory Science · 2021 · 34 citations · Full text

, , +15

Risk-Based Source Data Verification Approaches: Pros and Cons

Vadim Tantsyura, Imogene Grimes, Jules T. Mitchel et al. · Drug Information Journal · 2010 · 34 citations

, , +11

1–5 of 9

Authors

57

  1. JW
    Joel Waters

    Target (United States), United States

    3 publications · 89 citations

    3

    h-index

  2. VT
    Vadim Tantsyura

    Target (United States), United States

    3 publications · 89 citations

    3

    h-index

  3. KF
    Kaye Fendt

    PAREXEL International (United States), United States

    3 publications · 89 citations

    3

    h-index

  4. JT
    Jules T. Mitchel

    Target (United States), United States

    3 publications · 89 citations

    3

    h-index

  5. YJ
    Yong Joong Kim

    Oklahoma State University, United States

    2 publications · 55 citations

    2

    h-index

1–5 of 57

Institutions

28

  1. Target (United States)

    Minneapolis, United States

    3 h-index

    7 publications

    199 citations

  2. PAREXEL International (United States)

    Waltham, United States

    3 h-index

    6 publications

    191 citations

  3. Clinical Research Institute

    Plymouth, United States

    2 h-index

    2 publications

    55 citations

  4. Sanofi (United States)

    Bridgewater, United States

    2 h-index

    3 publications

    70 citations

  5. Bristol-Myers Squibb (Germany)

    Munich, Germany

    2 h-index

    3 publications

    107 citations

  6. Brown University

    Providence, United States

    1 h-index

    1 publications

    40 citations

  7. Eli Lilly (United States)

    Indianapolis, United States

    1 h-index

    1 publications

    48 citations

  8. IQVIA (United States)

    Durham, United States

    1 h-index

    3 publications

    48 citations

1–8 of 28

Venues

  1. Therapeutic Innovation & Regulatory Science

    TIRS · 6 publications · 164 citations

    6

    h-index

  2. Journal of the American Medical Directors Association

    JAMDA · 1 publications · 40 citations

    1

    h-index

  3. Clinical Trials

    1 publications · 18 citations

    1

    h-index

  4. Drug Information Journal

    DIA · 1 publications · 34 citations

    1

    h-index

1–4