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

Volume: 19, Issue: 1
Published: Nov 5, 2019
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 applications in an anonymised format. EMA Policy 0070 requires sponsors to demonstrate careful consideration of data utility within anonymised CSRs published within...
Paper Details
Title
European Medicines Agency Policy 0070: an exploratory review of data utility in clinical study reports for academic research
Published Date
Nov 5, 2019
Volume
19
Issue
1
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