Concepedia

Regulatory Data Standards

Regulatory Data Standards is a type of clinical data standard that specifies the structured formats, metadata, and terminologies required by governmental or international regulatory agencies to ensure the consistency, quality, and comparability of data submitted for the evaluation of medical products.

22

Publications

614

Citations

112

Authors

87

Institutions

Publications per year

2017–2026

8

Parents

Publications

22

Voltage to pressure conversion: are you getting `phased' by the problem?

Andrew Hurrell · Journal of Physics Conference Series · 2004 · 67 citations · Full text

, , +17

Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey

Rhonda Facile, Erin Elizabeth Muhlbradt, Mengchun Gong et al. · JMIR Medical Informatics · 2021 · 62 citations · Full text

, , +17

Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research

Reham Badawy, Farhan Hameed, Lauren Bataille et al. · Digital Biomarkers · 2019 · 45 citations · Full text

, , +17

When to include clinical study reports and regulatory documents in systematic reviews

Tom Jefferson, Peter Doshi, Isabelle Boutron et al. · BMJ evidence-based medicine · 2018 · 43 citations · Full text

, , +16

Harmonizing regulatory regimes for the governance of patient-generated health data

Jenifer Sunrise Winter, Elizabeth Davidson · Telecommunications Policy · 2021 · 39 citations · Full text

, , +13

1–5 of 22

Authors

112

  1. PA
    Paul A. Heidenreich

    VA Palo Alto Health Care System, United States

    2 publications · 59 citations

    2

    h-index

  2. RE
    Richard E. Kuntz

    Brigham and Women's Hospital, United States

    2 publications · 59 citations

    2

    h-index

  3. MJ
    Martha J. Radford

    Yale University, United States

    2 publications · 59 citations

    2

    h-index

  4. RF
    Rita F. Redberg

    University of California, San Francisco, United States

    2 publications · 59 citations

    2

    h-index

  5. EP
    Edward P. Havranek

    University of Colorado Denver, United States

    2 publications · 59 citations

    2

    h-index

1–5 of 112

Institutions

87

  1. National Cancer Institute

    Bethesda, United States

    2 h-index

    2 publications

    47 citations

  2. Clinical Research Consortium

    Las Vegas, United States

    2 h-index

    5 publications

    293 citations

  3. Radboud University Medical Center

    Nijmegen, The Netherlands

    1 h-index

    1 publications

    45 citations

  4. Christian-Albrechts-Universität zu Kiel

    Kiel, Germany

    1 h-index

    1 publications

    45 citations

  5. Cancer Research Foundation

    Henderson, United States

    1 h-index

    1 publications

    13 citations

  6. Precision Optics Corporation (United States)

    Gardner, United States

    1 h-index

    1 publications

    45 citations

  7. Manchester Academic Health Science Centre

    Manchester, United Kingdom

    1 h-index

    1 publications

    43 citations

  8. Johns Hopkins University

    Baltimore, United States

    1 h-index

    1 publications

    45 citations

1–8 of 87

Venues

  1. Circulation

    2 publications · 53 citations

    2

    h-index

  2. Journal of Biomedical Informatics

    1 publications · 35 citations

    1

    h-index

  3. BMJ evidence-based medicine

    1 publications · 43 citations

    1

    h-index

  4. The Quality Assurance Journal

    QA · 1 publications · 34 citations

    1

    h-index

  5. Health Care Policy and Politics A to Z

    1 publications · 28 citations

    1

    h-index

1–5