Bioequivalence and Bioavailability Forum • medical event before dosing

medical event before dosing [Study Performance]

posted by ratnakar1811 – India, 2011-06-15 12:41 (5080 d 09:07 ago) – Posting: # 7129
Views: 4,246

Dear All,
Reporting it as Medical event leads to the following queries:

Should it be considered for analysis of events in study report e.g. 12.2.2 Display of AE and 12.2.3 Analysis of AE such other sections of 12.2?
Where to record the event and in what format?
Should post study examination of the subject required to be performed?
Treatment can be given but should volunteer be paid full compensation?
Or simply mention it as an AE (provision to be made in the SOP) but relationship to the study drug can be “Not related”?

For your views members.

Regards,

Ratnakar

Complete thread:

medical event before dosing drsatishmc 2011-06-14 10:34
- medical event before dosing raghu 2011-06-14 12:09
  - medical event before dosingratnakar1811 2011-06-15 10:41
    - medical event before dosing swapnil.kuche 2011-06-16 11:22

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