GCP essential document retention

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    • #7723
      LRobison
      Participant

      Hello all,

      I’m interested to hear what processes you recommend for archiving electronic GCP essential documents to ensure they are accessable for audit in years to come. For clinical trials we may not be able to access Word documents over a period of time if there are significant software upgrades. Do all files need to be converted to a PDF/A? (This could be a big job!).

      Many thanks.

      Laura

    • #7758
      praxisaus
      Moderator

      Hi Laura. Good question!

      The EMA has some excellent guidance on this – and its best to archive in PDF (sorry). Its about ensuring integrity of data and data change history records.

      This link might be useful – refer to sections 5 and 6 in particular. The TGA adopts many of the EMA guidance – this is not one on their excluded list, so its safe to say if you follow this guidance you would be compliant with regulatory requirements.

      I would also always recommend you speak to the Sponsor and seek their advice too. 🙂

      https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf

      Melanie

    • #7802
      LRobison
      Participant

      Thanks Melanie!

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