Concepedia

Protocol Deviation Detection

Protocol Deviation Detection is a systematic method within clinical trial monitoring that identifies intentional or unintentional departures from the approved study protocol, thereby distinguishing itself from general monitoring activities by focusing specifically on adherence to predefined procedural, ethical, and regulatory requirements.

3

Publications

1.1K

Citations

21

Authors

14

Institutions

Publications per year

2017–2026

1

Parents

Publications

3

A tutorial on sensitivity analyses in clinical trials: the what, why, when and how

Lehana Thabane, Lawrence Mbuagbaw, Shiyuan Zhang et al. · BMC Medical Research Methodology · 2013 · 901 citations · Full text

, , +16

Clinical trials in psychiatry: should protocol deviation censor patient data?

Philip W. Lavori · PubMed · 1992 · 164 citations

, , +13

Protocol Deviations: A Holistic Approach from Defining to Reporting

Laura Galuchie, Catherine E. Stewart, Frank Meloni · Therapeutic Innovation & Regulatory Science · 2021 · 18 citations · Full text

, , +17

Benchmarking Protocol Deviations and Their Variation by Major Disease Categories

Kenneth Getz, Zachary Smith, Ananya Jain et al. · Therapeutic Innovation & Regulatory Science · 2022 · 10 citations · Full text

, , +11

1–4 of 3

Authors

21

  1. MB
    Monica Bawor

    McMaster University, Canada

    1 publications · 901 citations

    1

    h-index

  2. MM
    Maura Marcucci

    University of Milan, Italy

    1 publications · 901 citations

    1

    h-index

  3. BB
    Brittany B. Dennis

    McMaster University, Canada

    1 publications · 901 citations

    1

    h-index

  4. VF
    Vincent Fruci

    McMaster University, Canada

    1 publications · 901 citations

    1

    h-index

  5. SZ
    Shiyuan Zhang

    Harbin Medical University, China

    1 publications · 901 citations

    1

    h-index

1–5 of 21

Institutions

14

  1. Brown University

    Providence, United States

    1 h-index

    1 publications

    164 citations

  2. Population Health Research Institute

    Hamilton, Canada

    1 h-index

    2 publications

    1.8K citations

  3. Hamilton Health Sciences

    Hamilton, Canada

    1 h-index

    1 publications

    901 citations

  4. Pfizer (United Kingdom)

    Tadworth, United Kingdom

    1 h-index

    1 publications

    18 citations

  5. McMaster University

    Hamilton, Canada

    1 h-index

    14 publications

    12.6K citations

  6. University of Ottawa

    Ottawa, Canada

    1 h-index

    1 publications

    901 citations

  7. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    1 h-index

    1 publications

    18 citations

  8. GlaxoSmithKline (Canada)

    Mississauga, Canada

    1 h-index

    1 publications

    901 citations

1–8 of 14

Venues

  1. BMC Medical Research Methodology

    1 publications · 901 citations

    1

    h-index

  2. PubMed

    Repository · 1 publications · 164 citations

    1

    h-index

  3. Therapeutic Innovation & Regulatory Science

    TIRS · 1 publications · 18 citations

    1

    h-index

1–3