Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission [Bioanalytics]

posted by qualityassurance – 2024-06-04 07:25 (15 d 05:10 ago) – Posting: # 24019
Views: 645

Dear 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.

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

Regards,
QA

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