Concepedia

Protocol Deviations Management

Protocol Deviations Management is a systematic framework within clinical trial governance that identifies, documents, assesses, and corrects departures from approved study protocols to maintain data integrity, regulatory compliance, and participant safety.

27

Publications

4.8K

Citations

212

Authors

115

Institutions

Publications per year

2017–2026

12

Variants

Protocol Deviation Management

Parents

Publications

27

Clinical Trials: A Practical Approach.

Ira Hill, Stuart Pocock · Biometrics · 1984 · 3K citations

, , +16

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 a Practical Approach

2013 · 213 citations

, , +16

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

A.-W. Chan, A. Hrobjartsson, Peter C Gøtzsche et al. · BMJ · 2008 · 203 citations · Full text

, , +16

Mortality reduction after implementing a clinical practice guidelines–based management protocol for severe traumatic brain injury

Yaseen M. Arabi, Samir H. Haddad, Hani Tamim et al. · Journal of Critical Care · 2009 · 123 citations

, , +14

1–5 of 27

Authors

212

  1. MA
    Mark A. Musen

    Stanford University, United States

    2 publications · 71 citations

    2

    h-index

  2. RD
    Rejane Dillenburg

    McMaster University, Canada

    1 publications · 901 citations

    1

    h-index

  3. KK
    Katharina Kurpanek

    Heinrich Heine University Düsseldorf, Germany

    1 publications · 24 citations

    1

    h-index

  4. RA
    Robert A. Meguid

    University of Colorado Denver, United States

    1 publications · 14 citations

    1

    h-index

  5. DG
    Douglas G. Altman

    University of Oxford, United Kingdom

    1 publications · 203 citations

    1

    h-index

1–5 of 212

Institutions

115

  1. Mayo Clinic in Florida

    Jacksonville, United States

    2 h-index

    6 publications

    273 citations

  2. Mayo Clinic

    Rochester, United States

    2 h-index

    6 publications

    273 citations

  3. Mayo Clinic in Arizona

    Scottsdale, United States

    2 h-index

    6 publications

    273 citations

  4. Inserm

    Paris, France

    1 h-index

    4 publications

    252 citations

  5. Cochrane

    Copenhagen, Denmark

    1 h-index

    2 publications

    406 citations

  6. St Bartholomew's Hospital

    London, United Kingdom

    1 h-index

    1 publications

    19 citations

  7. Josai International University

    Tōgane, Japan

    1 h-index

    2 publications

    20 citations

  8. Kanazawa University

    Kanazawa, Japan

    1 h-index

    1 publications

    10 citations

1–8 of 115

Venues

  1. Cancer

    3 publications · 123 citations

    3

    h-index

  2. Perspectives in Clinical Research

    2 publications · 47 citations

    2

    h-index

  3. PubMed

    Repository · 2 publications · 71 citations

    2

    h-index

  4. Therapeutic Innovation & Regulatory Science

    TIRS · 2 publications · 42 citations

    2

    h-index

  5. BMJ Open Quality

    1 publications · 20 citations

    1

    h-index

1–5