blood sampling [Study Per­for­mance]

posted by Pankaj Mishra – Mumbai, India, 2009-12-10 11:05 (6031 d 00:20 ago) – Posting: # 4456
Views: 25,745

Dear Ratnakar,

❝ Generally we have a window of 2 min for inhouse sampling and for ambulatory samples we have a window of 1 hr mentioned in the protocol, now my question is should we use actual time for all the deviation irrespective as mentioned above (i.e. even the sample is delayed by 1 min also) or for only those samples for which protocol deviation required to be filed?

❝

❝ Currently we have mentioned actual time to be considered for all the deviations even it is for 1 min also.


I think we should use an acceptable limit of ± 2 minutes for all the samples whether in-house or ambulatory and we can mention this in our SOP. Why 1 hr for ambulatory when that is also scheduled? I don't think any regulatory may have an objection on this approach except for those case where we have first point Cmax and half life is very low (e.g. 1 hr). In those cases we may restrict ourselves to 1 min of acceptable deviation.

Regards,
Pankaj Mishra
—
Pankaj Mishra

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