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Sponsors of non-commercial clinical trials should carefully consider whether their data is ever likely to be used for regulatory purposes e.g. to support a new indication for a marketed medicinal product. In particular, if some of the source data has only been retained for 5 years as required by the Directive 2005/28/EC, they may no longer be available for inspection when the application is made and therefore would not be in compliance with provisions of Directive 2001/83/EC |
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