European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research

European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research

Abstract Background Clinical study reports (CSRs) have been increasingly utilised within academic research in recent years. European Medicines Agency (EMA) Policy 0070 ‘Phase 1,’ which came into effect in January 2015, requires the publication of regulatory documents such as CSRs from central applic...

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Bibliographic Details
Main Authors: Jean-Marc Ferran, Sarah J. Nevitt
Format: Article
Language:English
Published: BMC 2019-11-01
Series:BMC Medical Research Methodology
Subjects:
Policy 0070
Regulatory
Anonymised
Clinical study reports
Data utility
Review
Online Access:http://link.springer.com/article/10.1186/s12874-019-0836-3

Internet

http://link.springer.com/article/10.1186/s12874-019-0836-3

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