All samples might be informative [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2024-06-05 13:33 (13 d 23:12 ago) – Posting: # 24021
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Hi QA and Shreyas,

❝ What your study protocol and SOP says? If it is deviation from your SOP and protocol, file the deviation, take proper CAPA. I think this is suffice.

I agree.

❝ If final outcome of the study does not change with and without this subject, it does not seems any risk.

I would not perform two analyses for BE, only report the concentrations of the subject who withdraw consent. See the footnote of this post why in my CRO we analyzed all samples.

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