Concepedia

Protocol Deviation Metrics

Protocol Deviation Metrics is a formal measurement framework used in clinical research to quantify and categorize the frequency, type, and impact of departures from an approved study protocol, thereby distinguishing it from general compliance indicators by specifically tracking predefined deviations for quality, safety, and regulatory assessment purposes.

7

Publications

698

Citations

37

Authors

22

Institutions

Publications per year

2017–2026

3

Parents

Publications

7

Analysis of Longitudinal Trials with Protocol Deviation: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation

James R. Carpenter, James Roger, Michael G. Kenward · Journal of Biopharmaceutical Statistics · 2013 · 293 citations

, , +14

Assessment of Healthcare Worker Protocol Deviations and Self-Contamination During Personal Protective Equipment Donning and Doffing

Jennie H. Kwon, Carey‐Ann D. Burnham, Kimberly A. Reske et al. · Infection Control and Hospital Epidemiology · 2017 · 169 citations · Full text

, , +14

Choosing the analysis population in non-inferiority studies: per protocol or intent-to-treat

M. Matilde Sanchez, Xun Chen · Statistics in Medicine · 2006 · 148 citations

, , +16

Assessment and classification of protocol deviations

RavindraBhaskar Ghooi, Neelambari Bhosale, Reena Wadhwani et al. · Perspectives in Clinical Research · 2016 · 34 citations · Full text

, , +13

The Life Cycle and Management of Protocol Deviations

Katharina Kurpanek, Maryrose Petrizzo, Sonia Brenner et al. · Therapeutic Innovation & Regulatory Science · 2014 · 24 citations

, , +13

1–5 of 7

Authors

37

  1. MM
    M. Matilde Sanchez

    Maresme Health Consortium, Spain

    1 publications · 148 citations

    1

    h-index

  2. PD
    Pathik Divate

    Jehangir Hospital, India

    1 publications · 34 citations

    1

    h-index

  3. GA
    Grard A. P. Nieuwenhuijzen

    Radboud University Nijmegen, Netherlands

    1 publications · 12 citations

    1

    h-index

  4. NB
    Neelambari Bhosale

    Jehangir Clinical development Centre, India

    1 publications · 34 citations

    1

    h-index

  5. SS
    Sondra Seiler

    Washington University in St. Louis, United States

    1 publications · 169 citations

    1

    h-index

1–5 of 37

Institutions

22

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

    Rahway, United States

    2 h-index

    2 publications

    166 citations

  2. Link Consulting

    Lisbon, Portugal

    1 h-index

    1 publications

    24 citations

  3. Radboud University Nijmegen

    Nijmegen, The Netherlands

    1 h-index

    4 publications

    48 citations

  4. University Medical Center Utrecht

    Utrecht, The Netherlands

    1 h-index

    3 publications

    36 citations

  5. Catharina Ziekenhuis

    Eindhoven, Netherlands

    1 h-index

    4 publications

    48 citations

  6. Mercy Health

    Cincinnati, United States

    1 h-index

    1 publications

    24 citations

  7. Philip Morris International (Germany)

    Munich, Germany

    1 h-index

    1 publications

    24 citations

  8. Kirin (United States)

    Los Angeles, United States

    1 h-index

    1 publications

    24 citations

1–8 of 22

Venues

  1. Therapeutic Innovation & Regulatory Science

    TIRS · 2 publications · 42 citations

    2

    h-index

  2. Journal of Biopharmaceutical Statistics

    JBS · 1 publications · 293 citations

    1

    h-index

  3. Infection Control and Hospital Epidemiology

    ICHE · 1 publications · 169 citations

    1

    h-index

  4. Statistics in Medicine

    1 publications · 148 citations

    1

    h-index

  5. Clinical Nutrition

    1 publications · 12 citations

    1

    h-index

1–5