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Access to Non-Summary Clinical Trial Data for Research Purposes Under Eu Law
Daria Kim
(Author)
·
Springer
· Paperback
Access to Non-Summary Clinical Trial Data for Research Purposes Under Eu Law - Kim, Daria
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Synopsis "Access to Non-Summary Clinical Trial Data for Research Purposes Under Eu Law"
PART ONE: Setting the Scene.- Introduction.- The Context and the Problem in Focus.- Secondary Analysis of Clinical Trial Data - A Primer.- PART TWO: Analysis de lege lata, - Legal Sources of Control over and Access to Clinical Trial Data under the EU Applicable Framework.- Implications of IPD Disclosure for Statutory Innovation Incentives PART THREE: Analysis de lege ferenda.- Defining the Intervention Logic of Access-To-Data Measures - A Problem Analysis.- Access to Clinical Trial Data as a Case on R&D Externalities - A Theoretical Framework.- IPD as a Research Resource - Exclusively Controlled or Readily Accessible?.- Evaluating Legislative Options.- Final Conclusions and the Outlook
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The book is written in English.
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