Concepedia

Protocol Deviation Assessment

Protocol Deviation Assessment is a systematic evaluation method used in clinical trial auditing to identify, analyze, and classify departures from the approved study protocol in order to determine their impact on data integrity, participant safety, and regulatory compliance.

5

Publications

1.2K

Citations

36

Authors

20

Institutions

Publications per year

2017–2026

1

Parents

Publications

5

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

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

Assessment and classification of protocol deviations

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

, , +13

An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital

Sharmila Jalgaonkar, Shruti Bhide, Raakhi Tripathi et al. · PLoS ONE · 2016 · 24 citations · Full text

, , +16

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

1–5 of 5

Authors

36

  1. PC
    Peter C Gøtzsche

    Cochrane, Denmark

    1 publications · 203 citations

    1

    h-index

  2. ZS
    Zainab Samaan

    McMaster University, Canada

    1 publications · 901 citations

    1

    h-index

  3. LM
    Lawrence Mbuagbaw

    McMaster University, Canada

    1 publications · 901 citations

    1

    h-index

  4. RT
    Raakhi Tripathi

    King Edward Memorial Hospital and Seth G.S. Medical College, India

    1 publications · 24 citations

    1

    h-index

  5. JL
    Juneyoung Lee

    Korea University, South Korea

    1 publications · 901 citations

    1

    h-index

1–5 of 36

Institutions

20

  1. Mayo Clinic in Florida

    Jacksonville, United States

    1 h-index

    1 publications

    203 citations

  2. Jehangir Hospital

    Pune, India

    1 h-index

    5 publications

    170 citations

  3. Mayo Clinic

    Rochester, United States

    1 h-index

    1 publications

    203 citations

  4. Simon Fraser University

    Burnaby, Canada

    1 h-index

    1 publications

    901 citations

  5. King Edward Memorial Hospital and Seth G.S. Medical College

    Mumbai, India

    1 h-index

    7 publications

    168 citations

  6. McMaster University

    Hamilton, Canada

    1 h-index

    14 publications

    12.6K citations

  7. Population Health Research Institute

    Hamilton, Canada

    1 h-index

    2 publications

    1.8K citations

  8. Cochrane

    Copenhagen, Denmark

    1 h-index

    2 publications

    406 citations

1–8 of 20

Venues

  1. Perspectives in Clinical Research

    1 publications · 34 citations

    1

    h-index

  2. Therapeutic Innovation & Regulatory Science

    TIRS · 1 publications · 18 citations

    1

    h-index

  3. PLoS ONE

    1 publications · 24 citations

    1

    h-index

  4. BMJ

    1 publications · 203 citations

    1

    h-index

  5. BMC Medical Research Methodology

    1 publications · 901 citations

    1

    h-index

1–5