Bioequivalence and Bioavailability Forum • Adverse event capturing issue

Adverse event capturing issue [GxP / QC / QA]

posted by akh494 – 2008-09-17 08:51 (5694 d 06:06 ago) – Posting: # 2362
Views: 4,703
(edited by Ohlbe on 2008-09-17 10:03)

Hi all
I have question regarding Adverse event capturing
suppose a subject has fever which started on 09/9/2008 with severity mild, but on 11/9/2008 his fever is increased and so severity changed to Severe.
I just want to know how this adverse event will be reported in the CRF and in the database?

Please help regarding this matter.
regards
Ajay
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Edit: Category changed. [Ohlbe]

Complete thread:

Adverse event capturing issueakh494 2008-09-17 06:51
- Adverse event capturing issue Ohlbe 2008-09-17 10:03