handling of missing data [NCA / SHAM]

posted by Ohlbe – France, 2013-05-20 23:45 (3964 d 11:33 ago) – Posting: # 10609
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Dear Gracehung,

❝ As in BE study, One sample’s actual sampling time was miss recorded. However as according to protocol, this sample was analyzed by our analytical laboratory.


I understand you question differently from Helmut. My understanding is that the sample was collected, but the phlebotomist failed to record the actual blood sampling time. In such a case I would just file a protocol deviation and re-train the staff, full stop. Even if there were a sampling time deviation, the influence on the AUC 90 % CI is so limited that it would only change the outcome of the trial in a very borderline situation.

Regards
Ohlbe

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