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

Saved in:
Bibliographic Details
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
BMJ Publishing Group
Subjects
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
United States
South Africa
United Kingdom > UK
United States > US
Germany
India
Online AccessGet full text

Cover

More Information
Summary: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
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1756-1833
0959-8138
1756-1833
1468-5833
DOI:10.1136/bmj-2024-079701