Is the analysis of old samples always subject to GCP?

[markbellchambers]

We have clinical laboratory samples collected for future research under appropriate consent. This future research may take place after the trial has closed and be reported primarily in scientific papers as opposed to reporting in the bioanalytical report associated with the parent trial reporting. The samples might be older than one year beyond trial closure. Does GCP requirements still apply to the analysis?

[a123456]

Strange question. I assume that the IRB/IEC approved consent form signed by the participant, stated that they explicitly gave consent for future use of their sample? The EU CTR EU536/2014 does allow this future use, when the participant consents and under certain parameters. It also states that participants can withdraw their consent in the future and further analysis would not be possible. As the consent was according to GCP then I can only assume that GCP still applies, unless you have fully anonymised the samples so that can no longer be identified. You really need to look all this up and also the Human Tissue Act and Data Protection Act etc Of course your Ethics Committee would be able to advise on the legitimate use of anonymised samples.