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RegisterAdverse event [Regulatives / Guidelines]
HI Elmaestro,
Acc. to the above question the respond we got mentioned below:
It is investigator decision about relationship of drug. As per ICH GCP section 2.7, All medical decision should be taken by medically qualified person only.
So can you plz give the exact reason that the AE is related to the drug.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
❝ 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.
Acc. to the above question the respond we got mentioned below:
It is investigator decision about relationship of drug. As per ICH GCP section 2.7, All medical decision should be taken by medically qualified person only.
So can you plz give the exact reason that the AE is related to the drug.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- Adverse event Rameswari jena 2013-10-30 11:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adverse event ElMaestro 2013-10-30 12:15
- Adverse eventRameswari 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 eventRameswari jena 2013-10-30 12:49
- Adverse event Rameswari jena 2013-10-31 06:09
- Adverse event ElMaestro 2013-10-30 12:15
Ing. Helmut Schütz