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Analyst personnel blinding

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  • Anon
    13/01/2021 07:36
    Hello, For a BE study - when the number of samples collected is different for a test and reference product - how can the requirement of the analyst personnel being blinded to the treatment ensured?
  • RQA GLP Committee
    15/02/2021 13:05
    Dear Anon, it is not necessary for the analyst to be blinded, it is the person who will interpret the results who should be blinded. The analyst will have to prepare and analyse the samples but the results will be what they are and should not be influenced by the analyst - and even if they were blinded they probably could work out the difference anyway. The issue should be that the results should not be sent unblinded to anyone who should be blinded. If you are still concerned then this would have to be considered before the samples were collected. The sample numbers should be assigned in such a way as only those who need to know, understand the system. Then the analyst would only receive what would appear to be completely randomised numbers. Either that, or once the samples have been collected, they are randomised by someone independent of the study.
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