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EU Requirement for EDC systems backup in countries where study being conducted?



  • Janice Sarasola
    22/02/2018 11:42
    Does anyone know if it is an EU regulatory requirement that the EDC system being used has to have a backup server in the country in which the study was being conducted. Cannot find any reference to this request. Many thanks.
  • Matt Jones - Chair DIGIT Committee
    18/04/2018 09:28
    There's no direct requirement for an EDC to be backed up in the country that the study is taking place. Most EDC are SaaS (Software as a Service) and are cloud-based so the data is distributed rather than backed up. Rules around back up need to be followed where used, e.g. Back ups are not stored in the same location as the original data source.
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