Concepedia

Major Protocol Deviations

Major Protocol Deviations is a singular category of protocol deviation in clinical research that constitutes a significant departure from the approved study protocol, potentially impacting participant safety, data integrity, or regulatory compliance, thereby distinguishing it from minor deviations that do not substantially affect the study’s scientific validity or ethical conduct.

21

Publications

1.3K

Citations

195

Authors

127

Institutions

Publications per year

2017–2026

6

Parents

Publications

21

The Need to Revise the Declaration of Helsinki

Robert J. Levine · New England Journal of Medicine · 1999 · 262 citations

, , +14

Clinical Trials a Practical Approach

2013 · 213 citations

, , +16

QA makes a clinical trial stronger: Evidence-based medicine in radiation therapy

Damien C. Weber, M. Tomsej, Christos Melidis et al. · Radiotherapy and Oncology · 2012 · 192 citations · Full text

, , +16

A Randomized Trial of Postoperative Radiotherapy Versus Observation in Stage II and III Renal Adenocarcinoma

Peter Iversen, Valdemar Hvidt, Eywin Bruun et al. · Scandinavian Journal of Urology and Nephrology · 1987 · 119 citations

, , +12

Thrombolysis for Acute Stroke in Routine Clinical Practice

Dawn M. Bravata, Nancy Kim, John Concato et al. · Archives of Internal Medicine · 2002 · 116 citations

, , +16

1–5 of 21

Authors

195

  1. AF
    Akio Fujimura

    Jichi Medical University, Japan

    2 publications · 20 citations

    2

    h-index

  2. SO
    Shunsuke Ono

    The University of Tokyo, Japan

    2 publications · 20 citations

    2

    h-index

  3. KS
    Kazuyuki Saito

    Yamaguchi University, Japan

    2 publications · 20 citations

    2

    h-index

  4. EM
    Etsuko Miyamoto

    Kanazawa University, Japan

    1 publications · 10 citations

    1

    h-index

  5. MT
    M. Tomsej

    Cliniques Universitaires Saint-Luc, Belgium

    1 publications · 192 citations

    1

    h-index

1–5 of 195

Institutions

127

  1. Yale University

    New Haven, United States

    2 h-index

    2 publications

    378 citations

  2. Josai International University

    Tōgane, Japan

    2 h-index

    3 publications

    30 citations

  3. Jichi Medical University

    Shimotsuke, Japan

    2 h-index

    3 publications

    30 citations

  4. Hokuriku University

    Kanazawa, Japan

    2 h-index

    2 publications

    20 citations

  5. The University of Texas MD Anderson Cancer Center

    Houston, United States

    2 h-index

    3 publications

    134 citations

  6. Apple (Israel)

    Herzliya, Israel

    1 h-index

    21 publications

    1.4K citations

  7. Cytel (United States)

    Cambridge, United States

    1 h-index

    1 publications

    16 citations

  8. Tulane University

    New Orleans, United States

    1 h-index

    1 publications

    59 citations

1–8 of 127

Venues

  1. Journal of Clinical Oncology

    2 publications · 124 citations

    2

    h-index

  2. Annals of Clinical and Translational Neurology

    ACTN · 1 publications · 15 citations

    1

    h-index

  3. 1

    h-index

  4. American Journal of Clinical Oncology

    AJCO · 1 publications · 19 citations

    1

    h-index

  5. Ciência & Saúde Coletiva

    1 publications · 16 citations

    1

    h-index

1–5