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Hi Rameswari jena,
I must have misunderstood something. It sounds to me like you are asking if someone can justify the decision of your clincial staff to mark the AE as unrelated to the IMP??
Look up the delegation log, see who the PI has appointed to take care of AE scoring/drug relatedness/etc., get hold of that person and ask for a justification (should be the same who signed the (various) form(s) for that AE). If said person is clueless then you need to brew a story in the study report (be honest) and re-train her/him etc. Discuss the issue with the PI, too.
❝ Can anyone clarify my doubt? Its urgent? In one of our study one subject was dosed at 09:06 and he got vomiting at 09:20. The Cmax of the drug was between 30min-6 hrs (median 2 hrs). Finally the subject was withdrwn from the study but the AE was given as not related with the drug? Plz Justify?
I must have misunderstood something. It sounds to me like you are asking if someone can justify the decision of your clincial staff to mark the AE as unrelated to the IMP??
Look up the delegation log, see who the PI has appointed to take care of AE scoring/drug relatedness/etc., get hold of that person and ask for a justification (should be the same who signed the (various) form(s) for that AE). If said person is clueless then you need to brew a story in the study report (be honest) and re-train her/him etc. Discuss the issue with the PI, too.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Adverse event Rameswari jena 2013-10-30 11:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adverse eventElMaestro 2013-10-30 12:15
- Adverse event Rameswari jena 2013-10-30 12:49
- Adverse event ElMaestro 2013-10-30 13:27
- Adverse event Dr_Dan 2013-10-30 14:48
- Adverse event jag009 2013-10-30 14:59
- Adverse event Rameswari jena 2013-10-30 12:49
- Adverse event Rameswari jena 2013-10-31 06:09
- Adverse eventElMaestro 2013-10-30 12:15
Ing. Helmut Schütz