Regulation & Governance
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Dear all
I would appreciate clarification on the definition of ‘End of Trial’. Am I right to think that if your trial has biological samples which are being analysed as part of the primary or the secondary endpoint; then you cannot define the End of Trial as LPLV; instead you need to define it as ‘Last sample analysed’. we were informed that once a trial is declared ended the samples can no longer be held in the lab unless that lab is also HTA licensed becuas eth ethics to continue working on those samples has now ended; so best to define the End of Trial as the day the last samples are analysed.
Note: I am not referring to samples collected for further or exploratory endpoints; as these are normally used under other ethically approved projects).
Thank you for your help
best wishes
Joanna
Joanna Black
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