Concepedia

Protocol Deviation Reporting

Protocol Deviation Reporting is a formal procedural mechanism within clinical research that systematically identifies, documents, and communicates departures from an approved study protocol to ensure regulatory compliance, data integrity, and participant safety.

8

Publications

359

Citations

35

Authors

15

Institutions

Publications per year

2017–2026

2

Parents

Publications

8

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

Philip W. Lavori · PubMed · 1992 · 164 citations

, , +13

Enhanced Recovery after Elective Colorectal Surgery - Reasons for Non-Compliance with the Protocol

Didier Roulin, Mirza Muradbegovic, Valérie Addor et al. · Digestive Surgery · 2016 · 60 citations · Full text

, , +17

Failure to report protocol violations in clinical trials: a threat to internal validity?

Elizabeth A. Sweetman, Gordon S. Doig · Trials · 2011 · 45 citations · Full text

, , +16

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

Dynamic Evolution of Practice Guidelines: Analysis of Deviations From Assessment and Management Plans

Michael Farias, Kevin G. Friedman, Andrew J. Powell et al. · PEDIATRICS · 2012 · 24 citations · Full text

, , +16

1–5 of 8

Authors

35

  1. SB
    Shruti Bhide

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

    1 publications · 24 citations

    1

    h-index

  2. AD
    Animesh Das

    All India Institute of Medical Sciences, India

    1 publications · 10 citations

    1

    h-index

  3. LG
    Laura Galuchie

    Janssen (United States), United States

    1 publications · 18 citations

    1

    h-index

  4. AK
    Ashok K. Singh

    University of Nevada, Las Vegas, United States

    1 publications · 10 citations

    1

    h-index

  5. CB
    Catherine Blanc

    University Hospital of Lausanne, Switzerland

    1 publications · 60 citations

    1

    h-index

1–5 of 35

Institutions

15

  1. Boston Children's Hospital

    Boston, United States

    1 h-index

    6 publications

    144 citations

  2. Dr. Shroff’s Charity Eye Hospital

    Delhi, India

    1 h-index

    7 publications

    70 citations

  3. Janssen (United States)

    Hopewell, United States

    1 h-index

    1 publications

    18 citations

  4. Harvard University

    Cambridge, United States

    1 h-index

    6 publications

    144 citations

  5. UW Health University Hospital

    Madison, United States

    1 h-index

    2 publications

    28 citations

  6. Pfizer (United Kingdom)

    Tadworth, United Kingdom

    1 h-index

    1 publications

    18 citations

  7. University Hospital of Lausanne

    Lausanne, Switzerland

    1 h-index

    2 publications

    120 citations

  8. The University of Sydney

    Sydney, Australia

    1 h-index

    2 publications

    90 citations

1–8 of 15

Venues

  1. PEDIATRICS

    1 publications · 24 citations

    1

    h-index

  2. Trials

    1 publications · 45 citations

    1

    h-index

  3. PubMed

    Repository · 1 publications · 164 citations

    1

    h-index

  4. Indian Journal of Ophthalmology

    IJO · 1 publications · 10 citations

    1

    h-index

  5. Digestive Surgery

    1 publications · 60 citations

    1

    h-index

1–5