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biological sample transfer



  • Anon
    08/08/2019 08:41
    Protocols for two studies already archived stated that TK samples would be kept for 3 months and then disposed. However the Sponsor now wants these samples anlaysed in a non-GLP study. The non-GLP protocol references the GLP studies. Is this enough or should report amendments be isssued for the GLP studies in order to link the sample transfer to the non-GLP study?
  • RQA GLP Committee
    11/09/2019 14:53
    Dear Anon, If you add a note to file to each data package in the archive to document the change of circumstances for the samples, this should be sufficient.
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