Concepedia

Protocol Amendments

Protocol Amendments is a formal modification to the approved clinical trial protocol that specifies the rationale, procedural changes, and operational adjustments to ensure continued scientific validity, regulatory compliance, and participant safety within the framework of Good Clinical Practice.

98

Publications

8.8K

Citations

293

Authors

145

Institutions

Publications per year

2017–2026

24

Variants

Protocol Amendment

Parents

Children

Publications

98

World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects

Christiane, Druml, Wolzt et al. · 中国结合医学杂志：英文版 · 2001 · 3.4K citations

, , +8

The revision of the Declaration of Helsinki: past, present and future

Robert V. Carlson, Kenneth Boyd, David J. Webb · British Journal of Clinical Pharmacology · 2004 · 719 citations · Full text

, , +10

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

PubMed · 2006 · 413 citations

, , +10

<scp>FDA</scp> Modernization Act 2.0 allows for alternatives to animal testing

Jason J. Han · Artificial Organs · 2023 · 320 citations · Full text

, , +14

BCPT 2023 policy for experimental and clinical studies

Pernille Tveden‐Nyborg, Troels K. Bergmann, Niels Jessen et al. · Basic & Clinical Pharmacology & Toxicology · 2023 · 317 citations · Full text

, , +10

1–5 of 98

Authors

293

  1. KG
    Kenneth Getz

    Tufts University, United States

    5 publications · 348 citations

    5

    h-index

  2. WB
    William B. Hamlin

    Swedish Medical Center, United States

    2 publications · 41 citations

    2

    h-index

  3. KI
    Kenneth I. Kaitin

    Tufts University, United States

    2 publications · 223 citations

    2

    h-index

  4. PB
    Paul Bachner

    United Hospital, United States

    2 publications · 41 citations

    2

    h-index

  5. MN
    Markus Neuhäuser

    Koblenz University of Applied Sciences, Germany

    2 publications · 51 citations

    2

    h-index

1–5 of 293

Institutions

145

  1. Tufts University

    Medford, United States

    5 h-index

    12 publications

    886 citations

  2. University of Toronto

    Toronto, Canada

    3 h-index

    3 publications

    74 citations

  3. Koblenz University of Applied Sciences

    Koblenz, Germany

    2 h-index

    3 publications

    66 citations

  4. University of Edinburgh

    Edinburgh, United Kingdom

    2 h-index

    5 publications

    2.3K citations

  5. Biogen (United States)

    Cambridge, United States

    2 h-index

    2 publications

    141 citations

  6. American Urological Association

    Linthicum, United States

    2 h-index

    8 publications

    920 citations

  7. Duke University

    Durham, United States

    2 h-index

    9 publications

    981 citations

  8. Emory University

    Atlanta, United States

    2 h-index

    3 publications

    62 citations

1–8 of 145

Venues

  1. Diabetes Care

    10 publications · 253 citations

    10

    h-index

  2. EPPO Bulletin

    8 publications · 191 citations

    8

    h-index

  3. PubMed

    Repository · 8 publications · 656 citations

    7

    h-index

  4. JAMA

    4 publications · 192 citations

    4

    h-index

  5. Trials

    3 publications · 65 citations

    3

    h-index

1–5