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kamakshi ● 2006-12-29 09:30 (6711 d 11:47 ago) (edited on 2006-12-29 12:07) Posting: # 423 Views: 4,110 |
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Dear Sir, I seek advice on this piece of matter. Kindly let me know your views on capturing the impact of the protocol deviations on the study. Does it need te be evaluated. This is a concern as I could not find about this piece of information in regulatory guidelines though practically it is captured for studies. Could it be a matter of concern if the reason for a protocol deviation related to dosing with respect to noncompletion of 240 ml of water with study medication is captured as "unknown". thanks Kamakshi |
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paresh.mistry ● 2006-12-30 12:10 (6710 d 09:08 ago) @ kamakshi Posting: # 426 Views: 3,246 |
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Dear kamakshi, this is very intresting case for the study as the dosing done with the unknown amount of water. protocol deviation should be co relate with the out come of the study. as per my understanding the PD impact on the study. for this case its only recommended that collect the data from clinic if any amount can claim for the dosing and if not possible than wait for the final analysis from analytical deparment and check the trend if any outliers seen than it should be deleted from the final analysis in stat with the given proper reason for the tracing of PD and mentioned the trend detail of the subject with compare to other subject. i think i can little bit answer your question. expert can be commented and correct me. paresh mistry |
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