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
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.