Module 12 2019

Electronic Trial Master File – Exchange Mechanism Standard - DRAFT

• Defining a standardized and simple mechanism for transfer of eTMF Content (similar in approach to eCTD and CDSIC standards)

Content Export + XML

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• Envisaged to allow the exchange of artifacts or information between different systems could be automated • Archiving of eTMF Content • Use within Mergers/Acquisitions • Transfer from eTMF content from CROs to sponsors

The Organisation for Professionals in Regulatory Affairs