Good Clinical Practice Guide
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Thread: Redacting patient identifiers for research archiving

  1. #1
    Forum Member
    Join Date
    Jun 2019

    Redacting patient identifiers for research archiving

    Please can anyone offer some guidance with regards to whether there is regulation/policies to cover if patient identifiers should be redacted before a research study is archived, either off-site from an NHS organisation, but within the remit/contract for that organisation or with the sponsor for the study.

  2. #2
    Forum Member
    Join Date
    Nov 2011
    I donít understand. All documentation is covered by the GDPR and by Clinical Trial regulations requiring that subject data be treated as confidential. There are regulations that cover archiving and they require that the archive be secure and safe. The requirement for confidentiality and data protection still continue in that archive. So why would you need to remove all the subject identifiers? It is a requirement of GCP that the investigator/institution retain a confidential list of all trial subjects and their trial identifiers. So as this list will be in the Trial Master File, it will be in the archive and it cannot be deleted or redacted.
    Is the archive being put in a non-secure place? If so, it would be non-compliant with GCP legislation and probably a Serious Breach! The contract that the investigator/institution has with the archive provider will ensure proper security and confidentiality. Your institutionís archivist will know all about this and should have oversight of the archiving of all trials.

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