biological sample transfer
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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
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.
I think linking the GLP samples with the non GLP study can be done by stating clearly the source of samples in NON GLP study protocol.
this will automatically trigger for an amendment to the GLP study report if
1. Any study sample is completely used during the NON GLP study
2. If the Non GLP study is going beyond 3 months of storage period as mentioned in GLP report.
In these above cases or similar cases an amendment is required to the GLP reports.