This paper is in the following e-collection/theme issue:

Digital Health Reviews (1724) Ethics, Privacy, and Legal Issues (617) Innovations in Clinical Trials and Research Data Management (124)

Published on in Vol 24, No 5 (2022): May

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/33591, first published .
Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Authors of this article:

Nachiket Gudi1 Author Orcid Image ;   Prashanthi Kamath1 Author Orcid Image ;   Trishnika Chakraborty1 Author Orcid Image ;   Anil G Jacob1 Author Orcid Image ;   Shradha S Parsekar2 Author Orcid Image ;   Suptendra Nath Sarbadhikari1 Author Orcid Image ;   Oommen John3, 4 Author Orcid Image
Article Authors Cited by (18) Tweetations (12) Metrics

Journals

  1. Dsouza V, Pattanshetty S, Raj R, DS A, Gudi N, Brand H. Rapid review on monkeypox policies among the G20 nations: relevance to policy and practitioner. F1000Research 2022;11:1360 View
  2. Khan K, Fawzy M, Chien P. Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment. International Journal of Gynecology & Obstetrics 2023;163(3):733 View
  3. Kamath P, Gudi N, Staunton C, Jacob A, John O. Individual participant data sharing intentions and practices during the coronavirus disease-2019 pandemic: A rapid review. Data & Policy 2023;5 View
  4. Wilmes N, Hendriks C, Viets C, Cornelissen S, van Mook W, Cox-Brinkman J, Celi L, Martinez-Martin N, Gichoya J, Watkins C, Bakhshi-Raiez F, Wynants L, van der Horst I, van Bussel B. Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review. BMJ Global Health 2023;8(5):e012007 View
  5. Warner F, Tong B, McDougall J, Martin Ginis K, Rabchevsky A, Cragg J, Kramer J. Perspectives on Data Sharing in Persons With Spinal Cord Injury. Neurotrauma Reports 2023;4(1) View
  6. Labkoff S, Quintana Y, Rozenblit L. Identifying the capabilities for creating next-generation registries: a guide for data leaders and a case for “registry science”. Journal of the American Medical Informatics Association 2024;31(4):1001 View
  7. Ormond K, Bavamian S, Becherer C, Currat C, Joerger F, Geiger T, Hiendlmeyer E, Maurer J, Staub T, Vayena E. What are the bottlenecks to health data sharing in Switzerland? An interview study. Swiss Medical Weekly 2024;154(1):3538 View
  8. Coccia M. Digital Technology Ecotone to Revolutionize Health Sector. SSRN Electronic Journal 2024 View
  9. Staunton C, Blom J, Mascalzoni D. Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants. Frontiers in Medicine 2024;11 View
  10. Odem-Davis K, Taylor-Cousar J. Compassionate use trials and equitable access to variant-specific treatment for cystic fibrosis. The Lancet Respiratory Medicine 2024;12(11):842 View
  11. Mohan A, Jaihind Jothikaran T, Gudi N, A K A, Ashok L. Growing old before growing rich: a scoping review on ageing-related policy interventions from the WHO Southeast Asian Region. BMJ Open 2025;15(1):e079621 View
  12. Tanchangya T, Islam N, Naher K, Mia M, Chowdhury S, Sarker S, Rashid F. Financial Technology-Enabled Sustainable Finance for Small- and Medium-Sized Enterprises. Environment, Innovation and Management 2025;01 View
  13. Crealock-Ashurst B, Levanita S, Frischer S, Adhikari S, Mwebia W, Kadri-Alabi Z, Davidson L, Jeena L, Evans M, Morley G, Harriss E, Carson G, Norton A, Sigfrid L. PEARLES challenges and solutions to the implementation of clinical research responses to epidemics and pandemics: a scoping review. eClinicalMedicine 2025;85:103294 View
  14. Ahn J, Noh Y, Hu M, Shen X, Simonetto D, Kamath P, Loomba R, Shah V. AI-driven synthetic data generation for accelerating hepatology research: A study of the United Network for Organ Sharing (UNOS) database. Hepatology 2025 View
  15. Mahadik S, Sen P, Shah E. Harnessing digital health technologies and real-world evidence to enhance clinical research and patient outcomes. DIGITAL HEALTH 2025;11 View
  16. YANG J, QIN Y, WANG S, WU Q, WANG J, LI H, WU E, HUANG T, ZENG D, SHENG B. Extended reality in neurology: Technological analysis and clinical value. SCIENTIA SINICA Technologica 2025;55(10):1674 View

Books/Policy Documents

  1. Coccia M. Digital Entrepreneurship. View
  2. Ribeiro L, Dallavalle S, Kremer G, Stark R. Business Process Management: Responsible BPM Forum, Process Technology Forum, Educators Forum. View