Adverse event [GxP / QC / QA]

posted by taresh41  – Mumbai, 2009-08-17 15:13 (6149 d 03:12 ago) – Posting: # 4054
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Dear Bhavesh


I totally agree with KK, i would like to add to it, that you can report the Adverse events in two formats in final report i.e.

1) Adverse Events occurred during study (here you can mention the treatment).

2) Post study Adverse events (i.e Abnormal post study finding at the completion of the last period or last ambulatory of the last period.)

Hope this helps you Bhavesh.

Thanks & Regards,
Taresh

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