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Staff blood samples

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  • Anon
    23/09/2020 16:13
    Hi, For an assay validation requiring human blood samples, it has been proposed that staff blood samples are used instead of volunteer blood samples. What are the expectations and requirements for staff blood samples being used in this manner? Are they any different from volunteer samples with regards to informed consent and any other PID requirements? Thanks. (Originally raised in GCP forum)
  • Vanessa Grant
    05/11/2020 17:30
    You need to comply with the Human Tissues Act for any samples collected from staff. So you need informed consent, confidentiality in place and if you are in the UK you need an HTA licence (sorry don't know the laws in other countries).
  • RQA GLP Committee
    20/11/2020 09:32
    Dear Anon, Thank you Vanessa for your comments, we have nothing further to add.
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