Navigating US participant data sharing requirements: implications for international clinical trials

Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries

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Published inBMJ Vol. 386; p. e079701
Main Authors Dal-Ré, Rafael, Bekker, Linda-Gail, Jha, Vivekanand, Le Louarn, Anne, Naudet, Florian
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 06.09.2024
BMJ Publishing Group LTD
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Abstract Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries
AbstractList Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in other countries
Author Dal-Ré, Rafael
Jha, Vivekanand
Naudet, Florian
Bekker, Linda-Gail
Le Louarn, Anne
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  article-title: Data sharing governance in sub-Saharan Africa during public health emergencies: gaps and guidance
  publication-title: S Afr J Sci
  contributor:
    fullname: Brand
– ident: 2024090608100676000_386.sep06_10.e079701.6
  doi: 10.1038/d41586-019-01720-7
– ident: 2024090608100676000_386.sep06_10.e079701.39
  doi: 10.1136/bmj.q324
– ident: 2024090608100676000_386.sep06_10.e079701.34
– ident: 2024090608100676000_386.sep06_10.e079701.1
  doi: 10.1016/j.jclinepi.2022.05.019
– ident: 2024090608100676000_386.sep06_10.e079701.11
– ident: 2024090608100676000_386.sep06_10.e079701.33
  doi: 10.1001/jama.2018.10359
– ident: 2024090608100676000_386.sep06_10.e079701.38
– ident: 2024090608100676000_386.sep06_10.e079701.36
– ident: 2024090608100676000_386.sep06_10.e079701.15
– ident: 2024090608100676000_386.sep06_10.e079701.22
  doi: 10.1056/NEJMoa2031994
– ident: 2024090608100676000_386.sep06_10.e079701.13
– ident: 2024090608100676000_386.sep06_10.e079701.30
– ident: 2024090608100676000_386.sep06_10.e079701.29
  doi: 10.1038/s41591-023-02292-w
– ident: 2024090608100676000_386.sep06_10.e079701.4
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Snippet Rafael Dal-Ré and colleagues consider the challenges of new requirements to share individual participant data for US federally funded trials carried out in...
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SubjectTerms Analysis
Clinical trials
Clinical Trials as Topic
Consent
COVID-19
FDA approval
Funding
General Data Protection Regulation
Government agencies
Humans
Information Dissemination - methods
Information sharing
International Cooperation
Life Sciences
Personal information
R&D
Regulatory agencies
Research & development
Research ethics
United States
Title Navigating US participant data sharing requirements: implications for international clinical trials
URI https://bmj.com/content/386/bmj-2024-079701.full
https://www.ncbi.nlm.nih.gov/pubmed/39242115
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https://www.proquest.com/docview/3101794236
https://hal.science/hal-04714680
Volume 386
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