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Rameswari jena ☆ India, 2013-10-30 12:51 (4619 d 12:14 ago) Posting: # 11812 Views: 3,995 |
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Hello , 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? |
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ElMaestro ★★★ Denmark, 2013-10-30 13:15 (4619 d 11:49 ago) @ Rameswari jena Posting: # 11813 Views: 3,266 |
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Hi Rameswari jena, ❝ 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. — Pass or fail! ElMaestro |
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Rameswari jena ☆ India, 2013-10-30 13:49 (4619 d 11:16 ago) @ ElMaestro Posting: # 11814 Views: 3,282 |
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HI Elmaestro, ❝ 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] |
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ElMaestro ★★★ Denmark, 2013-10-30 14:27 (4619 d 10:37 ago) @ Rameswari jena Posting: # 11815 Views: 3,261 |
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Hi Rameswari jena, ❝ So can you plz give the exact reason that the AE is related to the drug. I absolutely can't. The staff, incl. notably PI and MD's, know the drug, they screened and interviewed the volunteers, they know and documented all the circumstances. Only they are the ones who can and must provide the argumentation. — Pass or fail! ElMaestro |
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Dr_Dan ★★ Germany, 2013-10-30 15:48 (4619 d 09:17 ago) @ Rameswari jena Posting: # 11817 Views: 3,244 |
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Dear Rameswari jena In general the Principal Investigator judges whether or not, in his/her opinion, the adverse drug reaction was related with the drug. In your case the adverse event is to be recorded as follows: Unlikely: if the clinical event has a temporal relationship to drug administration which makes a causal relationship improbable and in which other drugs, chemicals or underlying disease provide plausible explanation. Unrelated: if the clinical event can be explained by any reason excluding the administered drug. (So if your PI does not provide a reasonable explanation he/she can not categorize the event as unrelated.) Not assessable/unclassified: if the report suggesting an adverse event cannot be judged because information is insufficient or contradictory and which cannot be supplemented or verified. I hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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jag009 ★★★ NJ, 2013-10-30 15:59 (4619 d 09:05 ago) @ ElMaestro Posting: # 11818 Views: 3,225 |
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Hi ElMaestro, ❝ 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?? Will you be dressing up as an MD on Halloween?  just kidding. |
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Rameswari jena ☆ India, 2013-10-31 07:09 (4618 d 17:55 ago) @ Rameswari jena Posting: # 11833 Views: 3,188 |
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❝ Hello , ❝ ❝ 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? Hi Dan, Thanks for the respond. |
Ing. Helmut Schütz